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0 Diseases | | 3 Products |
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5 Trials |  |
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- | asivatrep (PAC-14028) / Amorepacific, tirbanibulin oral (KX2-391 oral) / Hanmi, Athenex, betamethasone/calcipotriol (BFH 772) / Novartis
Journal: Drug repositioning for rosacea disease: Biological TARGET identification, molecular docking, pharmacophore mapping, and molecular dynamics analysis. (Pubmed Central) - Sep 9, 2024
Similarly, considering drugs targeting SKAP2 and S100A7A interactome proteins, we found that pitavastatin and dasatinib exert stable interactions with SKAP2, and lovastatin and tirbanibulin with S100A7A...In conclusion, our study provides evidence for the possible contribution of SKAP2 and S100A7A to rosacea pathology. Furthermore, it provides significant information on the molecular interactions between drugs and these proteins, highlighting the importance of considering structural features and binding interactions in the design of targeted therapies for skin disorders such as rosacea.
- | burfiralimab (hzVSF(IgG4)) / Immunemed
Enrollment change, Trial termination: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Feb 15, 2024
P2, N=1, Terminated, Sponsor: ImmuneMed, Inc.
Furthermore, it provides significant information on the molecular interactions between drugs and these proteins, highlighting the importance of considering structural features and binding interactions in the design of targeted therapies for skin disorders such as rosacea. N=48 --> 1 | Recruiting --> Terminated; A new study combining Phase III clinical trials has been planned.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Trial completion: Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) (clinicaltrials.gov) - Feb 15, 2024
P1, N=72, Completed, Sponsor: ImmuneMed, Inc.
N=48 --> 1 | Recruiting --> Terminated; A new study combining Phase III clinical trials has been planned. Recruiting --> Completed
- || Review, Journal, Metastases: Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs. (Pubmed Central) - Jan 8, 2024
in 2017), tralokinumab (anti-IL-13 in 2021), lebrikizumab (anti-IL-13 in 2023), and the oral janus kinase (JAK) inhibitors (JAKi) targeting JAK1/2 (baricitinib in 2020 in the EU) or JAK1 (upadacitinib in 2021 and abrocitinib in 2022)...Among the topical therapies, tapinarof (aryl hydrocarbon receptor), ruxolitinib (JAK1/2i), delgocitinib (pan-JAKi), asivatrep (anti-transient receptor potential vanilloid), and phosphodiesterase-4-inhibitors (roflumilast, difamilast) are discussed. Among systemic therapies, current data on cord-blood-derived mesenchymal stem cells, CM310 (anti IL-4R?), nemolizumab (anti-IL-31RA), anti-OX40/OX40L-antibodies, neurokinin-receptor-1-antagonists, and difelikefalin (?-opioid-R) are reported.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) (clinicaltrials.gov) - Jun 15, 2023
P2a, N=32, Recruiting, Sponsor: ImmuneMed, Inc.
Among systemic therapies, current data on cord-blood-derived mesenchymal stem cells, CM310 (anti IL-4R?), nemolizumab (anti-IL-31RA), anti-OX40/OX40L-antibodies, neurokinin-receptor-1-antagonists, and difelikefalin (?-opioid-R) are reported. Active, not recruiting --> Recruiting | N=24 --> 32 | Trial completion date: Sep 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Mar 2024
- | asivatrep (PAC-14028) / Amorepacific
Journal: Study on the intervention effect and mechanism of bacillus Calmette-Guerin polysaccharide and nucleic acid injection on atopic dermatitis by targeting the transient receptor potential vanilloid subtype 1 pathway. (Pubmed Central) - Jun 22, 2022
Experiment 1: a total of 30 Kunming (KM) mice were randomized into blank control, model, BCG-PSN low-dose (25 g/kg), BCG-PSN medium-dose (75 g/kg), BCG-PSN high-dose (225 g/kg), and positive drug (hydrocortisone 25 mg/kg) control groups...A total of 20 KM mice were randomized into blank control, model, BCG-PSN, and BCG-PSN + PAC (PAC-14028) groups...In Experiment 2, after BCG-PSN was combined with PAC, the inflammation indexes decreased compared with those in the model group, and increased compared with those in the BCG-PSN group. Intramuscular BCG-PSN can target the TRPV1 pathway, inhibit inflammation, and improve the symptoms of AD mice.
- | hzVSF(IgG4) / Immunemed, Seoul National University Hospital
Journal: Double-Blind, Randomized, Placebo-Controlled Study on hzVSF-v13, a Novel Anti-Vimentin Monoclonal Antibody Drug as Add-on Standard of Care in the Management of Patients with Moderate to Severe COVID-19. (Pubmed Central) - Jun 11, 2022
Change from baseline of NEWS2 score at day 28 was -3.4 vs. + 0.4 (p = 0.0441). The results propose hzVSF-v13 as a candidate in the treatment of severe COVID-19.
- ||| asivatrep (PAC-14028) / Amorepacific
Clinical, P3 data, Journal: Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: A phase III, randomized, vehicle-controlled study (CAPTAIN-AD). (Pubmed Central) - Apr 13, 2022
The results propose hzVSF-v13 as a candidate in the treatment of severe COVID-19. Asivatrep improved clinical signs and symptoms of AD and was well tolerated.
- | SNUH-CD19-CAR-T / Seoul National University Hospital
Enrollment open, CAR T-Cell Therapy: Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Feb 22, 2022
P1, N=5, Recruiting, Sponsor: Seoul National University Hospital
Asivatrep improved clinical signs and symptoms of AD and was well tolerated. Not yet recruiting --> Recruiting
- | SNUH-CD19-CAR-T / Seoul National University Hospital
New P1 trial, CAR T-Cell Therapy: Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Jan 27, 2022
P1, N=5, Not yet recruiting, Sponsor: Seoul National University Hospital
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Trial completion: Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 1, 2021
P2, N=115, Completed, Sponsor: ImmuneMed, Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed
- || burfiralimab (hzVSF(IgG4)) / Immunemed
Enrollment open, Trial completion date, Trial primary completion date: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Aug 25, 2021
P2, N=48, Recruiting, Sponsor: ImmuneMed, Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Nov 2021
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed
Trial completion, Trial completion date, Trial primary completion date: Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Aug 25, 2021
P2, N=63, Completed, Sponsor: ImmuneMed, Inc.
Not yet recruiting --> Recruiting | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Nov 2021 Recruiting --> Completed | Trial completion date: May 2021 --> Aug 2021 | Trial primary completion date: Apr 2021 --> Aug 2021
- asivatrep (PAC-14028) / Amorepacific
EFFICACY AND SAFETY OF ASIVATREP CREAM FOR ATOPIC DERMATITIS: A PLACEBOCONTROLLED, RANDOMIZED PHASE III CLINICAL TRIAL (CAPTAIN-AD)* () - Apr 23, 2021 - Abstract #ISAD2021ISAD_182;
P3
No significant safety issues were reported. Asivatrep cream was effective and well-tolerated in patients with mild to moderate AD.
- asivatrep (PAC-14028) / Amorepacific
EFFICACY AND SAFETY OF PAC-14028 CREAM, A NOVEL, TOPICAL, NONSTEROIDAL, SELECTIVE TRPV1 ANTAGONIST IN PATIENTS WITH MILD TO MODERATE ATOPIC DERMATITIS: A PHASE IIB RANDOMIZED TRIAL () - Apr 23, 2021 - Abstract #ISAD2021ISAD_105;
No significant safety issues were reported. PAC-14028 cream may be an effective and safe option for the treatment of patients with mild-to-moderate AD.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Trial completion: Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - Apr 2, 2021
P1, N=56, Completed, Sponsor: ImmuneMed, Inc.
PAC-14028 cream may be an effective and safe option for the treatment of patients with mild-to-moderate AD. Enrolling by invitation --> Completed
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P1 trial: Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) (clinicaltrials.gov) - Mar 25, 2021
P1, N=72, Recruiting, Sponsor: ImmuneMed, Inc.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed
Enrollment open: Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Jan 5, 2021
P2, N=63, Recruiting, Sponsor: ImmuneMed, Inc.
Enrolling by invitation --> Completed Not yet recruiting --> Recruiting
- || HzVSFv-13 / Immunemed, Seoul National University Hospital
Clinical, Journal: Compassionate use of hzVSF-v13 in two patients with severe COVID-19. (Pubmed Central) - Dec 31, 2020
Both patients, including an 81-year-old man who required extracorporeal membrane oxygenation, showed clinical improvement. These results warrant placebo-controlled trials to evaluate the hzVSF-v13 efficacy against COVID-19.
- | asivatrep (PAC-14028) / Amorepacific
Preclinical, Journal: A TRPV1 antagonist, PAC-14028 does not increase the risk of tumorigenesis in chemically induced mouse skin carcinogenesis. (Pubmed Central) - Dec 30, 2020
On Day 169, 1.0% (20 mg/kg/day) of PAC-14028 in female mice resulted in a C and AUC of 12916.0 ng/mL and 78962.9 ng‧hr/mL, respectively. PAC-14028 cream was well tolerated and did not increase the risk of skin tumorigenesis in two-stage carcinogenesis study.
- || burfiralimab (hzVSF(IgG4)) / Immunemed
New P2 trial: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 22, 2020
P2, N=48, Not yet recruiting, Sponsor: ImmuneMed, Inc.
- |||| burfiralimab (hzVSF(IgG4)) / Immunemed
New P2 trial: Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 22, 2020
P2, N=63, Not yet recruiting, Sponsor: ImmuneMed, Inc.
- |||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P2 trial: Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 21, 2020
P2, N=105, Recruiting, Sponsor: ImmuneMed, Inc.
- || asivatrep (PAC-14028) / Amorepacific
Clinical, Journal: Novel therapeutic approach with PAC-14028 cream, a TRPV1 antagonist, for patients with mild-to-moderate atopic dermatitis. (Pubmed Central) - Jul 7, 2020
PAC-14028 cream was well tolerated and did not increase the risk of skin tumorigenesis in two-stage carcinogenesis study. No abstract available
- || asivatrep (PAC-14028) / Amorepacific
Clinical, P2b data, Journal: Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial. (Pubmed Central) - Jul 5, 2020
No abstract available PAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild-to-moderate AD.
- || asivatrep (PAC-14028) / Amorepacific
Clinical, Journal: Recent Therapeutic Advances in Pruritus Management for Atopic Dermatitis Patients: A Welcome Addition of Asivatrep to Our Arsenal of Future Topical Treatments. (Pubmed Central) - May 27, 2020
PAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild-to-moderate AD. No abstract available
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Enrollment open, Trial primary completion date: Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - Dec 3, 2018
P1, N=56, Enrolling by invitation, Sponsor: ImmuneMed, Inc.
No abstract available Not yet recruiting --> Enrolling by invitation | Trial primary completion date: May 2019 --> Aug 2019
- | asivatrep (PAC-14028) / Amorepacific
Trial completion, Trial primary completion date: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis (clinicaltrials.gov) - Nov 20, 2018
P1/2, N=56, Completed, Sponsor: Amorepacific Corporation
Not yet recruiting --> Enrolling by invitation | Trial primary completion date: May 2019 --> Aug 2019 Active, not recruiting --> Completed | Trial primary completion date: Dec 2018 --> Sep 2018
- | asivatrep (PAC-14028) / Amorepacific
Trial completion: CAPTAIN-AD-301: CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis (clinicaltrials.gov) - Nov 20, 2018
P3, N=240, Completed, Sponsor: Amorepacific Corporation
Active, not recruiting --> Completed | Trial primary completion date: Dec 2018 --> Sep 2018 Active, not recruiting --> Completed
- | burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P1 trial: Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - Aug 31, 2018
P1, N=56, Not yet recruiting, Sponsor: ImmuneMed, Inc.
- || asivatrep (PAC-14028) / Amorepacific
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis (clinicaltrials.gov) - Jul 5, 2018
P1/2, N=56, Active, not recruiting, Sponsor: Amorepacific Corporation
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Dec 2018 | Trial primary completion date: Mar 2018 --> Dec 2018
- ||||| asivatrep (PAC-14028) / Amorepacific
Enrollment closed, Trial completion date, Trial primary completion date: CAPTAIN-AD-301: CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis (clinicaltrials.gov) - Jun 25, 2018
P3, N=240, Active, not recruiting, Sponsor: Amorepacific Corporation
Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Dec 2018 | Trial primary completion date: Mar 2018 --> Dec 2018 Recruiting --> Active, not recruiting | Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Aug 2017 --> Dec 2018
- || asivatrep (PAC-14028) / Amorepacific
Trial primary completion date: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis (clinicaltrials.gov) - Aug 29, 2017
P1/2, N=56, Recruiting, Sponsor: Amorepacific Corporation
Recruiting --> Active, not recruiting | Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Aug 2017 --> Dec 2018 Trial primary completion date: Dec 2016 --> Mar 2018
- |||||| asivatrep (PAC-14028) / Amorepacific
Enrollment open: CAPTAIN-AD-301: CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis (clinicaltrials.gov) - Dec 15, 2016
P3, N=240, Recruiting, Sponsor: Amorepacific Corporation
Trial primary completion date: Dec 2016 --> Mar 2018 Not yet recruiting --> Recruiting
- |||||||||| asivatrep (PAC-14028) / Amorepacific
New P3 trial: CAPTAIN-AD-301: CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis (clinicaltrials.gov) - Nov 16, 2016
P3, N=240, Not yet recruiting, Sponsor: Amorepacific Corporation
- |||| asivatrep (PAC-14028) / Amorepacific
Trial completion: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea (clinicaltrials.gov) - Sep 20, 2016
P2, N=216, Completed, Sponsor: Amorepacific Corporation
Not yet recruiting --> Recruiting Recruiting --> Completed
- |||| asivatrep (PAC-14028) / Amorepacific
Trial completion: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis (clinicaltrials.gov) - Sep 20, 2016
P2, N=192, Completed, Sponsor: Amorepacific Corporation
Recruiting --> Completed Active, not recruiting --> Completed
- ||| asivatrep (PAC-14028) / Amorepacific
Enrollment closed: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis (clinicaltrials.gov) - Jul 15, 2016
P2, N=192, Active, not recruiting, Sponsor: Amorepacific Corporation
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| asivatrep (PAC-14028) / Amorepacific
Trial completion: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus (clinicaltrials.gov) - Jul 15, 2016
P2, N=296, Completed, Sponsor: Amorepacific Corporation
Recruiting --> Active, not recruiting Recruiting --> Completed
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis (clinicaltrials.gov) - May 2, 2016
P2, N=216, Recruiting, Sponsor: Amorepacific Corporation
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis (clinicaltrials.gov) - Apr 25, 2016
P2, N=75, Completed, Sponsor: Amorepacific Corporation
- | asivatrep (PAC-14028) / Amorepacific
Trial completion, Trial primary completion date: A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects (clinicaltrials.gov) - Apr 22, 2016
P1, N=24, Completed, Sponsor: Amorepacific Corporation
Recruiting --> Completed Not yet recruiting --> Completed | Trial primary completion date: Mar 2015 --> Apr 2016
- ||||| asivatrep (PAC-14028) / Amorepacific
New P1/2 trial: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis (clinicaltrials.gov) - Apr 22, 2016
P1/2, N=56, Recruiting, Sponsor: Amorepacific Corporation
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea (clinicaltrials.gov) - Oct 23, 2015
P2, N=216, Recruiting, Sponsor: Amorepacific Corporation
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis (clinicaltrials.gov) - Oct 23, 2015
P2, N=74, Completed, Sponsor: Amorepacific Corporation
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus (clinicaltrials.gov) - Oct 1, 2015
P2, N=294, Recruiting, Sponsor: Amorepacific Corporation
- | asivatrep (PAC-14028) / Amorepacific
New P1 trial: A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects (clinicaltrials.gov) - Dec 6, 2014
P1, N=24, Not yet recruiting, Sponsor: Amorepacific Corporation
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients (clinicaltrials.gov) - Jan 30, 2014
P2, N=80, Completed, Sponsor: Amorepacific Corporation
- ||||| asivatrep (PAC-14028) / Amorepacific
New P2 trial: Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus (clinicaltrials.gov) - Jan 30, 2014
P2, N=74, Completed, Sponsor: Amorepacific Corporation
- |||| asivatrep (PAC-14028) / Amorepacific
Trial completion: Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients (clinicaltrials.gov) - Jan 30, 2014
P2, N=80, Completed, Sponsor: Amorepacific Corporation
Not yet recruiting --> Completed | Trial primary completion date: Mar 2015 --> Apr 2016 Not yet recruiting --> Completed