Nxera Pharma Trials - LARVOL Sigma

63 Trials

Active Trials

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Trial + Data / Events

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Region

Interventions

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Primary compl

Study compl

Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Nxera Pharma

2013-001445-13: Assessment of the early bronchodilation of Glycopyrronium bromide compared to Tiotropium in patients with moderate to severe COPD

Not yet recruiting

150

Europe

Glycopyrronium bromide, Spiriva Handihaler, NVA237, Inhalation powder, hard capsule, Seebri Breezhaler, Spiriva Handihaler

Novartis Pharma GmbH, Novartis Pharma GmbH

Chronic Obstructive Pulmonary Disease (COPD), COPD is a chronic condition of the lungs which causes people to suffer symptoms such as shortness of breath and coughing., Diseases [C] - Respiratory Tract Diseases [C08]

2021-004972-32: Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children (6 to less than 12 years) with asthma. Farmacocinética, farmacodinámica, seguridad y tolerabilidad de bromuro de glicopirronio en niños con asma (de 6 a menos de 12 años de edad).

Ongoing

Europe, RoW

Glycopyrronium bromide 25 μg of active moiety in the capsule, Glycopyrronium bromide 12.5 μg of active moiety in the capsule, NVA237, Inhalation powder, hard capsule, Seebri Breezhaler

Novartis Farmacéutica, S.A., Novartis Pharma AG, Novartis Pharma AG

Asthma Asma, Asthma Asma, Diseases [C] - Respiratory Tract Diseases [C08]

NCT05222529 / 2021-004972-32: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma

Recruiting

Europe, RoW

Glycopyrronium bromide 25ug, NVA237, Placebo, Glycopyrronium bromide 12.5ug

Novartis Pharmaceuticals, Novartis Pharma AG

Asthma

07/27

08/27

AD 337 / Nxera Pharma

2005-005194-30: A multi-centre, randomised, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.

Ongoing

200

Europe

AD 337 20 mg Capsule, AD 337,

Arakis Ltd.

Fibromyalgia

Ultibro (glycopyrronium/indacaterol) / Novartis

2016-001435-13: Description of the ability to learn how to handle inhaler devices in COPD Etude descriptive de la capacité d’apprendre à utiliser des systèmes d’inhalation dans la bronchopneumopathie chronique obstructive

Ongoing

Europe

Inhalation powder, hard capsule, Inhalation solution, Inhalation powder, pre-dispensed, Ultibro® Breezhaler® 110/50 μg, Spiriva® Respimat® 2,5 μg, Seretide® Diskus® 500/50 μg

CHU de Bordeaux, CHU de Bordeaux

Chronic Obstructive Pulmonary Disease (COPD) Bronchopneumopathie chronique obstructive (BPCO), Chronic Obstructive Pulmonary Disease (COPD) Bronchopneumopathie chronique obstructive (BPCO), Diseases [C] - Respiratory Tract Diseases [C08]

2015-000473-12: The effectiveness of single dose Ultibro by Breezhaler versus ipratropium/salbutamol by nebulizer

Not yet recruiting

Europe

indacaterol maleate/glycopyrronium bromide, ipratropium/salbutamol, QVA149, Inhalation powder, hard capsule, Nebuliser liquid, Ultibro Breezhaler (indacaterol/glycopyrronium), Combivent, salbutamol/ipratropium

UMCG, UMCG, Novartis

COPD, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease, Diseases [C] - Respiratory Tract Diseases [C08]

2019-003351-11: Study to the effects of using "triple therapy" on the health status of COPD patients with characteristics of asthma Een onderzoek naar het effect van het gebruik van “triple therapie” op de gezondheids-status van COPD-patiënten met kenmerken van asthma

Not yet recruiting

316

Europe

Trimbow, Pressurised inhalation, Inhalation powder, Trimbow, Anoro or Duaklir Genuair Inhalationpowder or Ultibro Breezhaler or Spiolto Respimat

GPRI, General Practitioners Research Institute (GPRI)

Chronic Obstructive Pulmonary Disease (COPD) patients COPD patiënten, COPD COPD, Diseases [C] - Respiratory Tract Diseases [C08]

ChiCTR2100043128: Efficacy and cardiovascular adverse effects of Long-acting inhaled dual bronchodilation

Recruiting

receive QVA149 110/50 mg ;receive Tiotropium 18 μg

The First Affiliated Hospital of Shantou University Medical College; The First Affiliated Hospital of Shantou University Medical College, Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Shantou University Medical College

Chronic Obstructive Pulmonary Disease

ANTES B+, NCT06282861: Clinical Trial

Recruiting

1028

Europe

Trelegy Ellipta 100/62.5/25Mcg Inh 30D, LABA/LAMA/ICS, Brimica, LABA/LAMA, Duaklir, Ultibro, Ulunar, Xoterna, Anoro, Laventair, Spiolto Respimat, Yanimo, Foradil, LABA, Broncoral, Formoterol stada, Oxis, Formatris, Formoterol Aldo, Onbrez, Oslif, Hirobriz, Striverdi, Beglan, Betamican, Inaspir, Serevent, Soltel, Eklira, LAMA, Bretaris, Seebri, Tovanor, Enurev, Spiriva, Tavulus, Sirkava, Braltus, Gregal, Incruse, Rolufta

Fundacio Privada Mon Clinic Barcelona, GlaxoSmithKline

Chronic Obstructive Pulmonary Disease

09/25

Pulmonary function and treatment in patients with pulmonary hypertension, ChiCTR2200063362: The pulmonary function / airway resistance and treatment in patients with pulmonary hypertension

Not yet recruiting

100

indacaterol/glycopyrronium bromide powder for inhalation ;the conventional treatment of pulmonary hypertension

Qilu Hospital of Shandong University; Qilu Hospital of Shandong University, self-financing

pulmonary hypertension

NCT06643078: A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD

Recruiting

474

RoW

HL231 Solution for Inhalation, Ultibro 110μg/50 μg

Haisco Pharmaceutical Group Co., Ltd., Sichuan Haisco Pharmaceutical Group Co., Ltd

Chronic Obstructive Pulmonary Disease (COPD)

10/25

ChiCTR2300068316: A multicenter, randomized, placebo-controlled clinical study to evaluate the safety and efficacy of HL231 inhalation solution in the treatment of chronic obstructive pulmonary disease (COPD)

Not yet recruiting

B, F, D (B: 261 μg/141 μg HL231 inhalation solution; D: Jierun Ultibro 110 μg/50 μg); F: 261 μg/120 μg HL231 inhalation solution) ;D, B, F (B: 261 μg/141 μg HL231 inhalation solution; D: Jierun Ultibro 110 μg/50 μg); F: 261 μg/120 μg HL231 inhalation solution) ;F, D, B (B: 261 μg/141 μg HL231 inhalation solution; D: Jierun Ultibro 110 μg/50 μg); F: 261 μg/120 μg HL231 inhalation solution) ;D, F, B (B: 261 μg/141 μg HL231 inhalation solution; D: Jierun Ultibro 110 μg/50 μg); F: 261 μg/120 μg HL231 inhalation solution) ;F, B, D (B: 261 μg/141 μg HL231 inhalation solution; D: Jierun Ultibro 110 μg/50 μg); F: 261 μg/120 μg HL231 inhalation solution) ;B, D, F (B: 261 μg/141 μg HL231 inhalation solution; D: Jierun Ultibro 110 μg/50 μg); F: 261 μg/120 μg HL231 inhalation solution)

West China Hospital, Sichuan University; West China Hospital, Sichuan University, Haisco Pharmaceutical Group Co., Ltd.

Chronic obstructive pulmonary disease (COPD)

NCT06035393: A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Recruiting

200

RoW

HRG2005 inhalation, Placebo to match HRG2005 inhalation, Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation, Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

Jiangsu HengRui Medicine Co., Ltd.

Chronic Obstructive Pulmonary Disease

08/25

cenerimod (ACT-334441) / Viatris

2022-002814-17: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Not yet recruiting

420

Europe, RoW

Cenerimod, ACT-334441, Film-coated tablet

Idorsia Pharmaceuticals Ltd, Idorsia Pharmaceuticals Ltd

Moderate to severe systemic lupus erythematosus, Lupus, Diseases [C] - Immune System Diseases [C20]

2022-002815-47: A research study to evaluate the efficacy and safety of cenerimod in subjects suffering from Systemic Lupus Erythematosus

Not yet recruiting

420

Europe, RoW

Cenerimod, ACT-334441, Film-coated tablet

Idorsia Pharmaceuticals Ltd, Idorsia Pharmaceuticals Ltd

Moderate to severe systemic lupus erythematosus, Lupus, Diseases [C] - Immune System Diseases [C20]

OPUS OLE, NCT06475742: Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

Enrolling by invitation

680

Europe, US, RoW

Cenerimod, ACT-334441

Idorsia Pharmaceuticals Ltd.

Lupus Erythematosus, Systemic

05/28

OPUS-2, NCT05672576 / 2022-002815-47: A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

Recruiting

420

Europe, Japan, US, RoW

Cenerimod, ACT-334441, Placebo

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd

Lupus Erythematosus, Systemic

10/26

05/27

OPUS-1, NCT05648500 / 2022-002814-17: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Recruiting

420

Europe, US, RoW

Cenerimod, ACT-334441, Placebo

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd

Lupus Erythematosus, Systemic

10/26

05/27

NCT05004311: The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

Completed

Europe

Cenerimod, ACT-334441

Idorsia Pharmaceuticals Ltd.

Healthy, Renal Impairment

07/23

08/23

NCT04819464: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod

Completed

Europe

Cenerimod, ACT-334441

Idorsia Pharmaceuticals Ltd.

Healthy, Hepatic Impairment

08/24

NBI-1117568 / Neurocrine

NCT06963034: NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Recruiting

284

NBI-1117568, Placebo

Neurocrine Biosciences

Schizophrenia

10/27

NBI-1117568-SCZ2028, NCT05545111: Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Completed

210

NBI-1117568, Placebo

Neurocrine Biosciences

Schizophrenia

07/24

imaradenant (AZD4635) / AstraZeneca

NCT04089553: An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer

Completed

AZD4635, Oleclumab, MEDI9447, Durvalumab, Imfinzi, MEDI4736

AstraZeneca

Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer (mCRPC)

06/21

04/23

2020-000209-10: Phase II two-arm study of AZD4635 in combination with durvalumab and in combination with cabazitaxel and durvalumab in patients with mCRPC

Not yet recruiting

160

Europe

Durvalumab, Cabazitaxel, AZD4635, MEDI4736, Capsule, hard, Concentrate for solution for infusion, Concentrate and solvent for concentrate for solution for infusion, Jevtana

AstraZeneca AB, ASTRAZENECA AB, AstraZeneca AB

Progressive Metastatic Castrate-Resistant Prostate Cancer, Prostate Cancer, Diseases [C] - Cancer [C04]

NCT03381274: Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study

Active, not recruiting

1/2

US, RoW

Oleclumab, MEDI9447, Osimertinib, Tagrisso®, AZD4635

MedImmune LLC

Carcinoma, Non-Small-Cell Lung

05/21

04/26

NCT02740985: A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

Jul 2018 - Dec 2018 : For advanced solid tumours

Completed

313

AZD4635, Durvalumab, MEDI4736, Abiraterone Acetate, Zytiga, Enzalutamide, Xtandi, Oleclumab, MEDI9447, Docetaxel, Taxotere

AstraZeneca

Advanced Solid Malignancies, Non-Small Cell Lung Cancer (NSCLC), Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC), Colorectal Carcinoma (CRC)

12/20

03/23

TMP-301 / Tempero Bio

TMP-301-AUD-201, NCT06648655: A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder

Recruiting

100

TMP-301, Placebo

Tempero Bio, Inc.

Alcohol Use Disorder (AUD)

11/25

NCT06025396: Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

Completed

TMP-301, Placebo

Tempero Bio, Inc., National Institute on Drug Abuse (NIDA)

Cocaine Use Disorder, Substance Use Disorders, Healthy Volunteers

12/23

01/24

TMP-301-CUD-102, NCT06648668: A Study to Investigate the Interaction Between TMP-301 and Cocaine.

Completed

TMP-301, Placebo

Tempero Bio, Inc.

Cocaine Use Disorder

05/25

Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis

2019-001762-14: Anti-inflammatory effects of Glycopyrronium Ontstekingsremmend effect Glycopyrronium

Not yet recruiting

Europe

QMF149, QVM149, Inhalation powder

University Medical Center Groningen, Novartis Pharma AG

Asthma, Asthma, Diseases [C] - Respiratory Tract Diseases [C08]

NCT05776927: A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.

Not yet recruiting

304

QVM149, Salmeterol Xinafoate / Fluticasone Propionate, Placebo to QVM149, Placebo to Salmeterol Xinafoate / Fluticasone Propionate, Run-In Medication, Rescue Medication, Concept 1 Device, Girohaler

Novartis Pharmaceuticals

Asthma

03/26

02/29

ADITION, NCT04656223: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Completed

N/A

434

Europe

MF/IND/GLY plus sensor system, FDC therapy

Novartis Pharmaceuticals

Asthma

01/23

ChiCTR2300079273: Effect of Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose triple formulation on pulmonary function, symptoms and inflammation control in patients with asthma complicated with COPD

Not yet recruiting

N/A

Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose (160/150/50μg,qd); Budesonide formoterol inhalation powder aerosol (160/4.5 micrograms, 2 inhalations per bid) plus tiotropium bromide inhaler (2.5 micrograms, once a day, 2 inhalations per inhalation); Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol (160/4.8/7.2μg,bid,2 inhalations per inhalation)

Lishui People's Hospital; LiShui people's hospital, China Medical Foundation

asthma-COPD overlap

NCT05274425: A 24-week rPMS Study in Real-world Setting for Enerzair

Recruiting

N/A

600

RoW

Enerzair 150/50/80 μg, Enerzair 150/50/160 μg

Novartis Pharmaceuticals

Asthma

03/27

Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma

NCT05597020: A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Completed

Europe, US

Daridorexant, Placebo

Idorsia Pharmaceuticals Ltd.

Insomnia Disorder, Nocturia

04/24

DARIDOR-ALZ, NCT05924425: Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

Recruiting

Europe

Daridorexant 50 mg, Placebo, Polysomnography, Neuropsychological assessment, Questionnaires on sleep and behavioural problems, Actimetrics, 24-hour Ambulatory Blood Pressure Monitoring (ABPM, Biomarker assay

University Hospital, Montpellier, Idorsia Pharmaceuticals Ltd.

Alzheimer Disease, Insomnia Disorder, Sleep

05/26

03/27

NCT07028697: A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Recruiting

160

RoW

Daridorexant, Placebo

Nxera Pharma Korea Co., Ltd.

Insomnia Disorder

10/25

NCT06010693: A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Completed

206

RoW

Daridorexant, Placebo

Jiangsu Simcere Pharmaceutical Co., Ltd.

Insomnia Disorder

04/24

05/24

NCT06630390: Daridorexant to Prevent Delirium After Heart Surgery

Completed

Daridorexant 50 mg, Placebo

University of Rochester

POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINE

02/25

NCT05423717 / 2021-003867-87: Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

Recruiting

150

Europe, US

Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd

Insomnia

03/26

04/26

NCT05948540: Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

Recruiting

200

Intervention C Daridorexant, Intervention C Placebo

Global Coalition for Adaptive Research, U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline

Post Traumatic Stress Disorder

03/26

09/26

NCT05422612: Department of Defense PTSD Adaptive Platform Trial - Master Protocol

Recruiting

800

Intervention A Fluoxetine Hydrochloride (HCl), Intervention A Placebo, Intervention B Vilazodone Hydrochloride (HCl), Intervention B Placebo, Intervention C Daridorexant, Intervention C Placebo, Intervention D SLS-002, Intervention D Placebo

Global Coalition for Adaptive Research, U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline

Post Traumatic Stress Disorder

03/26

09/26

NCT03686995: Study to Evaluate the PK of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

Not yet recruiting

Europe

ACT-541468

University Hospital, Basel, Switzerland, Idorsia Pharmaceuticals Ltd.

Hepatic Impairment

06/19

NCT05458193: A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

Completed

Europe

Daridorexant, ACT-541468, Placebo

Idorsia Pharmaceuticals Ltd.

Obstructive Sleep Apnea of Adult

02/23

NCT05702177: A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented

Completed

Europe

Daridorexant 25 mg, Quviviq, Daridorexant 50 mg, Placebo

Idorsia Pharmaceuticals Ltd.

Healthy

04/23

NCT05632393: A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

Completed

Daridorexant

Idorsia Pharmaceuticals Ltd.

Healthy

04/23

NCT05877222: A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

Completed

Daridorexant 10 mg, Daridorexant 25 mg

Idorsia Pharmaceuticals Ltd.

Healthy

08/23

NCT06326723: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects

Completed

RoW

Daridorexant

Jiangsu Simcere Pharmaceutical Co., Ltd.

Healthy Volunteer

12/23

02/24

NCT06393504: Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Active, not recruiting

N/A

2095

Daridorexant, QUVIVIQ, Non-orexin receptor antagonist insomnia medication, No insomnia medication

Idorsia Pharmaceuticals Ltd., Carelon Research

Insomnia Disorder

04/28

NCT06311864: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

Enrolling by invitation

N/A

100

Canada

Daridorexant 50 mg, QUVIVIQ

PeriPharm, Idorsia Pharmaceuticals Ltd.

Insomnia

10/25

NCT06498128: Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

Recruiting

N/A

785

Europe, Canada, US

Daridorexant, QUVIVIQ, Non-orexin receptor antagonist medications for insomnia, No insomnia medication

Idorsia Pharmaceuticals Ltd., Iqvia Pty Ltd

Insomnia

03/33

lotiglipron (PF-07081532) / Pfizer

NCT05579977 / 2022-002834-15: Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

Terminated

902

Europe, Canada, Japan, US, RoW

PF-07081532, Placebo, Rybelsus

Pfizer, Pfizer Inc.

Diabetes Mellitus, Obesity

07/23

09/23

2022-002834-15: Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With T2DM and Separately PF-07081532 in People With Obesity Klinické hodnocení zkoumající hodnocený léčivý přípravek (PF-07081532) a přípravek Rybelsus u osob s diabetem 2. typu a samostatně podávaný přípravek PF-07081532 u osob s obezitou.

Not yet recruiting

780

RoW, Europe

20mg PF-07081532-82, 60mg PF-07081532-82, 100mg PF-07081532-82, 3mg Rybelsus, 7mg Rybelsus, 14mg Rybelsus, PF-07081532-82, Tablet, Rybelsus

Pfizer Inc., Pfizer Inc.

Type 2 Diabetes Mellitus and Obesity, Type 2 Diabetes Mellitus and Obesity, Body processes [G] - Metabolic Phenomena [G03]

NCT05677867: A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

Completed

Formulation A (PF-07081532 20 mg plus 60 mg), Formulation B (PF-07081532 80 mg)

Pfizer

Overweight, Obesity

03/23

NCT05652647: A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men

Completed

Europe

Oral [14C]PF-07081532, Oral PF-07081532 and IV [14C]PF-07081532

Pfizer

Healthy Participants

03/23

NCT05478603: A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

Completed

PF-07081532

Pfizer

Hepatic Impairment, Healthy Volunteers

04/23

NCT05745701: A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults

Completed

PF-07081532, Cyclosporine, Itraconazole

Pfizer

Healthy

05/23

NCT05510245: A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Terminated

PF-07081532

Pfizer

Type 2 Diabetes, Renal Impairment

07/23

NCT05788328: A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants

Terminated

Dabigatran etexilate (DE), Pradaxa, Rosuvastatin, Crestor, PF-07081532, Lotiglipron

Pfizer

Healthy

09/23

NCT05671653: A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range

Terminated

PF-07081532, Semaglutide, Wegovy, Ozempic

Pfizer

Obesity

11/23

PF-07258669 / Pfizer

NCT05113940: A Study of PF-07258669 In Healthy Adult Participants

Completed

120

Europe

PF-07258669, Placebo, Midazolam

Pfizer

Healthy Participants

07/23

NCT06706869: A Study to Learn if the Study Medicine Called Itraconazole and if Food Changes How the Body Processes the Other Study Medicine Called PF 07258669 in Older Adults or Healthy Adults

Completed

PF-07258669, Itraconazole

Pfizer

Healthy

01/25

02/25

NXE0039732 / Nxera Pharma

NCT05944237: HTL0039732 in Participants With Advanced Solid Tumours

Recruiting

1/2

150

Europe

HTL0039732 Capsules, HTL0039732 Capsules and atezolizumab infusion

Cancer Research UK, Nxera Pharma UK Limited

Neoplasms, Prostatic Neoplasms, Castration-Resistant, Stomach Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Mesothelioma, Malignant, Uterine Cervical Neoplasms, Kidney Neoplasms, Sarcoma, Pheochromocytomas

06/27

Undisclosed IBD therapeutic / Captor Therap, Nxera Pharma

No trials found

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Nxera Pharma

2013-001445-13: Assessment of the early bronchodilation of Glycopyrronium bromide compared to Tiotropium in patients with moderate to severe COPD

Not yet recruiting

150

Europe

Glycopyrronium bromide, Spiriva Handihaler, NVA237, Inhalation powder, hard capsule, Seebri Breezhaler, Spiriva Handihaler

Novartis Pharma GmbH, Novartis Pharma GmbH

Ongoing

Europe, RoW

Glycopyrronium bromide 25 μg of active moiety in the capsule, Glycopyrronium bromide 12.5 μg of active moiety in the capsule, NVA237, Inhalation powder, hard capsule, Seebri Breezhaler

Novartis Farmacéutica, S.A., Novartis Pharma AG, Novartis Pharma AG

Asthma Asma, Asthma Asma, Diseases [C] - Respiratory Tract Diseases [C08]

NCT05222529 / 2021-004972-32: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma

Recruiting

Europe, RoW

Glycopyrronium bromide 25ug, NVA237, Placebo, Glycopyrronium bromide 12.5ug

Novartis Pharmaceuticals, Novartis Pharma AG

Asthma

07/27

08/27

AD 337 / Nxera Pharma

Ongoing

200

Europe

AD 337 20 mg Capsule, AD 337,

Arakis Ltd.

Fibromyalgia

Ultibro (glycopyrronium/indacaterol) / Novartis

Ongoing

Europe

Inhalation powder, hard capsule, Inhalation solution, Inhalation powder, pre-dispensed, Ultibro® Breezhaler® 110/50 μg, Spiriva® Respimat® 2,5 μg, Seretide® Diskus® 500/50 μg

CHU de Bordeaux, CHU de Bordeaux

2015-000473-12: The effectiveness of single dose Ultibro by Breezhaler versus ipratropium/salbutamol by nebulizer

Not yet recruiting

Europe

UMCG, UMCG, Novartis

COPD, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease, Diseases [C] - Respiratory Tract Diseases [C08]

Not yet recruiting

316

Europe

Trimbow, Pressurised inhalation, Inhalation powder, Trimbow, Anoro or Duaklir Genuair Inhalationpowder or Ultibro Breezhaler or Spiolto Respimat

GPRI, General Practitioners Research Institute (GPRI)

Chronic Obstructive Pulmonary Disease (COPD) patients COPD patiënten, COPD COPD, Diseases [C] - Respiratory Tract Diseases [C08]

ChiCTR2100043128: Efficacy and cardiovascular adverse effects of Long-acting inhaled dual bronchodilation

Recruiting

receive QVA149 110/50 mg ;receive Tiotropium 18 μg

Chronic Obstructive Pulmonary Disease

ANTES B+, NCT06282861: Clinical Trial

Recruiting

1028

Europe

Fundacio Privada Mon Clinic Barcelona, GlaxoSmithKline

Chronic Obstructive Pulmonary Disease

09/25

Pulmonary function and treatment in patients with pulmonary hypertension, ChiCTR2200063362: The pulmonary function / airway resistance and treatment in patients with pulmonary hypertension

Not yet recruiting

100

indacaterol/glycopyrronium bromide powder for inhalation ;the conventional treatment of pulmonary hypertension

Qilu Hospital of Shandong University; Qilu Hospital of Shandong University, self-financing

pulmonary hypertension

NCT06643078: A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD

Recruiting

474

RoW

HL231 Solution for Inhalation, Ultibro 110μg/50 μg

Haisco Pharmaceutical Group Co., Ltd., Sichuan Haisco Pharmaceutical Group Co., Ltd

Chronic Obstructive Pulmonary Disease (COPD)

10/25

Not yet recruiting

West China Hospital, Sichuan University; West China Hospital, Sichuan University, Haisco Pharmaceutical Group Co., Ltd.

Chronic obstructive pulmonary disease (COPD)

NCT06035393: A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Recruiting

200

RoW

Jiangsu HengRui Medicine Co., Ltd.

Chronic Obstructive Pulmonary Disease

08/25

cenerimod (ACT-334441) / Viatris

2022-002814-17: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Not yet recruiting

420

Europe, RoW

Cenerimod, ACT-334441, Film-coated tablet

Idorsia Pharmaceuticals Ltd, Idorsia Pharmaceuticals Ltd

Moderate to severe systemic lupus erythematosus, Lupus, Diseases [C] - Immune System Diseases [C20]

2022-002815-47: A research study to evaluate the efficacy and safety of cenerimod in subjects suffering from Systemic Lupus Erythematosus

Not yet recruiting

420

Europe, RoW

Cenerimod, ACT-334441, Film-coated tablet

Idorsia Pharmaceuticals Ltd, Idorsia Pharmaceuticals Ltd

Moderate to severe systemic lupus erythematosus, Lupus, Diseases [C] - Immune System Diseases [C20]

OPUS OLE, NCT06475742: Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

Enrolling by invitation

680

Europe, US, RoW

Cenerimod, ACT-334441

Idorsia Pharmaceuticals Ltd.

Lupus Erythematosus, Systemic

05/28

OPUS-2, NCT05672576 / 2022-002815-47: A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

Recruiting

420

Europe, Japan, US, RoW

Cenerimod, ACT-334441, Placebo

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd

Lupus Erythematosus, Systemic

10/26

05/27

OPUS-1, NCT05648500 / 2022-002814-17: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Recruiting

420

Europe, US, RoW

Cenerimod, ACT-334441, Placebo

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd

Lupus Erythematosus, Systemic

10/26

05/27

NCT05004311: The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

Completed

Europe

Cenerimod, ACT-334441

Idorsia Pharmaceuticals Ltd.

Healthy, Renal Impairment

07/23

08/23

NCT04819464: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod

Completed

Europe

Cenerimod, ACT-334441

Idorsia Pharmaceuticals Ltd.

Healthy, Hepatic Impairment

08/24

NBI-1117568 / Neurocrine

NCT06963034: NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Recruiting

284

NBI-1117568, Placebo

Neurocrine Biosciences

Schizophrenia

10/27

NBI-1117568-SCZ2028, NCT05545111: Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Completed

210

NBI-1117568, Placebo

Neurocrine Biosciences

Schizophrenia

07/24

imaradenant (AZD4635) / AstraZeneca

NCT04089553: An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer

Completed

AZD4635, Oleclumab, MEDI9447, Durvalumab, Imfinzi, MEDI4736

AstraZeneca

Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer (mCRPC)

06/21

04/23

2020-000209-10: Phase II two-arm study of AZD4635 in combination with durvalumab and in combination with cabazitaxel and durvalumab in patients with mCRPC

Not yet recruiting

160

Europe

Durvalumab, Cabazitaxel, AZD4635, MEDI4736, Capsule, hard, Concentrate for solution for infusion, Concentrate and solvent for concentrate for solution for infusion, Jevtana

AstraZeneca AB, ASTRAZENECA AB, AstraZeneca AB

Progressive Metastatic Castrate-Resistant Prostate Cancer, Prostate Cancer, Diseases [C] - Cancer [C04]

NCT03381274: Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study

Active, not recruiting

1/2

US, RoW

Oleclumab, MEDI9447, Osimertinib, Tagrisso®, AZD4635

MedImmune LLC

Carcinoma, Non-Small-Cell Lung

05/21

04/26

NCT02740985: A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

Jul 2018 - Dec 2018 : For advanced solid tumours

Completed

313

AZD4635, Durvalumab, MEDI4736, Abiraterone Acetate, Zytiga, Enzalutamide, Xtandi, Oleclumab, MEDI9447, Docetaxel, Taxotere

AstraZeneca

Advanced Solid Malignancies, Non-Small Cell Lung Cancer (NSCLC), Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC), Colorectal Carcinoma (CRC)

12/20

03/23

TMP-301 / Tempero Bio

TMP-301-AUD-201, NCT06648655: A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder

Recruiting

100

TMP-301, Placebo

Tempero Bio, Inc.

Alcohol Use Disorder (AUD)

11/25

NCT06025396: Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

Completed

TMP-301, Placebo

Tempero Bio, Inc., National Institute on Drug Abuse (NIDA)

Cocaine Use Disorder, Substance Use Disorders, Healthy Volunteers

12/23

01/24

TMP-301-CUD-102, NCT06648668: A Study to Investigate the Interaction Between TMP-301 and Cocaine.

Completed

TMP-301, Placebo

Tempero Bio, Inc.

Cocaine Use Disorder

05/25

Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis

2019-001762-14: Anti-inflammatory effects of Glycopyrronium Ontstekingsremmend effect Glycopyrronium

Not yet recruiting

Europe

QMF149, QVM149, Inhalation powder

University Medical Center Groningen, Novartis Pharma AG

Asthma, Asthma, Diseases [C] - Respiratory Tract Diseases [C08]

Not yet recruiting

304

QVM149, Salmeterol Xinafoate / Fluticasone Propionate, Placebo to QVM149, Placebo to Salmeterol Xinafoate / Fluticasone Propionate, Run-In Medication, Rescue Medication, Concept 1 Device, Girohaler

Novartis Pharmaceuticals

Asthma

03/26

02/29

ADITION, NCT04656223: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Completed

N/A

434

Europe

MF/IND/GLY plus sensor system, FDC therapy

Novartis Pharmaceuticals

Asthma

01/23

Not yet recruiting

N/A

Lishui People's Hospital; LiShui people's hospital, China Medical Foundation

asthma-COPD overlap

NCT05274425: A 24-week rPMS Study in Real-world Setting for Enerzair

Recruiting

N/A

600

RoW

Enerzair 150/50/80 μg, Enerzair 150/50/160 μg

Novartis Pharmaceuticals

Asthma

03/27

Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma

NCT05597020: A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Completed

Europe, US

Daridorexant, Placebo

Idorsia Pharmaceuticals Ltd.

Insomnia Disorder, Nocturia

04/24

DARIDOR-ALZ, NCT05924425: Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

Recruiting

Europe

University Hospital, Montpellier, Idorsia Pharmaceuticals Ltd.

Alzheimer Disease, Insomnia Disorder, Sleep

05/26

03/27

NCT07028697: A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Recruiting

160

RoW

Daridorexant, Placebo

Nxera Pharma Korea Co., Ltd.

Insomnia Disorder

10/25

NCT06010693: A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Completed

206

RoW

Daridorexant, Placebo

Jiangsu Simcere Pharmaceutical Co., Ltd.

Insomnia Disorder

04/24

05/24

NCT06630390: Daridorexant to Prevent Delirium After Heart Surgery

Completed

Daridorexant 50 mg, Placebo

University of Rochester

POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINE

02/25

NCT05423717 / 2021-003867-87: Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

Recruiting

150

Europe, US

Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd

Insomnia

03/26

04/26

NCT05948540: Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

Recruiting

200

Intervention C Daridorexant, Intervention C Placebo

Global Coalition for Adaptive Research, U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline

Post Traumatic Stress Disorder

03/26

09/26

NCT05422612: Department of Defense PTSD Adaptive Platform Trial - Master Protocol

Recruiting

800

Global Coalition for Adaptive Research, U.S. Army Medical Research and Development Command, PPD Development, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline

Post Traumatic Stress Disorder

03/26

09/26

NCT03686995: Study to Evaluate the PK of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

Not yet recruiting

Europe

ACT-541468

University Hospital, Basel, Switzerland, Idorsia Pharmaceuticals Ltd.

Hepatic Impairment

06/19

NCT05458193: A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

Completed

Europe

Daridorexant, ACT-541468, Placebo

Idorsia Pharmaceuticals Ltd.

Obstructive Sleep Apnea of Adult

02/23

NCT05702177: A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented

Completed

Europe

Daridorexant 25 mg, Quviviq, Daridorexant 50 mg, Placebo

Idorsia Pharmaceuticals Ltd.

Healthy

04/23

NCT05632393: A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

Completed

Daridorexant

Idorsia Pharmaceuticals Ltd.

Healthy

04/23

NCT05877222: A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

Completed

Daridorexant 10 mg, Daridorexant 25 mg

Idorsia Pharmaceuticals Ltd.

Healthy

08/23

NCT06326723: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects

Completed

RoW

Daridorexant

Jiangsu Simcere Pharmaceutical Co., Ltd.

Healthy Volunteer

12/23

02/24

NCT06393504: Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Active, not recruiting

N/A

2095

Daridorexant, QUVIVIQ, Non-orexin receptor antagonist insomnia medication, No insomnia medication

Idorsia Pharmaceuticals Ltd., Carelon Research

Insomnia Disorder

04/28

NCT06311864: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

Enrolling by invitation

N/A

100

Canada

Daridorexant 50 mg, QUVIVIQ

PeriPharm, Idorsia Pharmaceuticals Ltd.

Insomnia

10/25

NCT06498128: Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

Recruiting

N/A

785

Europe, Canada, US

Daridorexant, QUVIVIQ, Non-orexin receptor antagonist medications for insomnia, No insomnia medication

Idorsia Pharmaceuticals Ltd., Iqvia Pty Ltd

Insomnia

03/33

lotiglipron (PF-07081532) / Pfizer

NCT05579977 / 2022-002834-15: Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

Terminated

902

Europe, Canada, Japan, US, RoW

PF-07081532, Placebo, Rybelsus

Pfizer, Pfizer Inc.

Diabetes Mellitus, Obesity

07/23

09/23

Not yet recruiting

780

RoW, Europe

20mg PF-07081532-82, 60mg PF-07081532-82, 100mg PF-07081532-82, 3mg Rybelsus, 7mg Rybelsus, 14mg Rybelsus, PF-07081532-82, Tablet, Rybelsus

Pfizer Inc., Pfizer Inc.

Type 2 Diabetes Mellitus and Obesity, Type 2 Diabetes Mellitus and Obesity, Body processes [G] - Metabolic Phenomena [G03]

NCT05677867: A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

Completed

Formulation A (PF-07081532 20 mg plus 60 mg), Formulation B (PF-07081532 80 mg)

Pfizer

Overweight, Obesity

03/23

NCT05652647: A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men

Completed

Europe

Oral [14C]PF-07081532, Oral PF-07081532 and IV [14C]PF-07081532

Pfizer

Healthy Participants

03/23

NCT05478603: A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

Completed

PF-07081532

Pfizer

Hepatic Impairment, Healthy Volunteers

04/23

NCT05745701: A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults

Completed

PF-07081532, Cyclosporine, Itraconazole

Pfizer

Healthy

05/23

NCT05510245: A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Terminated

PF-07081532

Pfizer

Type 2 Diabetes, Renal Impairment

07/23

NCT05788328: A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants

Terminated

Dabigatran etexilate (DE), Pradaxa, Rosuvastatin, Crestor, PF-07081532, Lotiglipron

Pfizer

Healthy

09/23

Terminated

PF-07081532, Semaglutide, Wegovy, Ozempic

Pfizer

Obesity

11/23

PF-07258669 / Pfizer

NCT05113940: A Study of PF-07258669 In Healthy Adult Participants

Completed

120

Europe

PF-07258669, Placebo, Midazolam

Pfizer

Healthy Participants

07/23

NCT06706869: A Study to Learn if the Study Medicine Called Itraconazole and if Food Changes How the Body Processes the Other Study Medicine Called PF 07258669 in Older Adults or Healthy Adults

Completed

PF-07258669, Itraconazole

Pfizer

Healthy

01/25

02/25

NXE0039732 / Nxera Pharma

NCT05944237: HTL0039732 in Participants With Advanced Solid Tumours

Recruiting

1/2

150

Europe

HTL0039732 Capsules, HTL0039732 Capsules and atezolizumab infusion

Cancer Research UK, Nxera Pharma UK Limited

06/27

Undisclosed IBD therapeutic / Captor Therap, Nxera Pharma

No trials found

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