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- || saridegib oral (IPI 926 oral) / Infinity Pharma, patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
P2 data, Journal: Phase 2 Trial of Topical Application of the Hedgehog Inhibitor Patidegib in Patients With Gorlin Syndrome. (Pubmed Central) - Nov 17, 2024
Patidegib Topical Gel warrants further clinical development.
- saridegib oral (IPI 926 oral) / Infinity Pharma, patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
A phase 3, randomized controlled trial of topical patidegib gel 2% in patients with Gorlin syndrome (Auditorium) - Sep 17, 2024 - Abstract #EADV2024EADV_5555;
A new Phase 3 trial designed to investigate patidegib 2% gel in PTCH1+/- GS patients with a high burden of facial BCCs at baseline has been opened at Sites in the EU, UK, and USA. 25 SEPTEMBER - 28 SEPTEMBER 2024 POWERED BY M-ANAGE.COM
- |||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment open: Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults with Gorlin Syndrome (clinicaltrials.gov) - Jan 31, 2024
P3, N=140, Recruiting, Sponsor: Sol-Gel Technologies, Ltd.
25 SEPTEMBER - 28 SEPTEMBER 2024 POWERED BY M-ANAGE.COM Not yet recruiting --> Recruiting
- |||||||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
New P3 trial: Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults with Gorlin Syndrome (clinicaltrials.gov) - Sep 22, 2023
P3, N=140, Not yet recruiting, Sponsor: Sol-Gel Technologies, Ltd.
- || patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Review, Journal: Topical Delivery of Hedgehog Inhibitors: Current Status and Perspectives. (Pubmed Central) - Nov 27, 2022
In clinical trials, only topical patidegib and sonidegib led to at least a partial response in 26/86 BCCs and 30/34 patients, respectively...In conclusion, the incomplete clinical response could be due to poor HHi uptake, biodistribution or biological response over time. Novel topical delivery techniques may improve HHi delivery, but additional research on cutaneous pharmacokinetics and biological response is needed.
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Journal: Recent advances in chemical composition and transdermal delivery systems for topical bio-actives in skin cancer. (Pubmed Central) - Sep 4, 2022
In particular, significant studies have been made, including modification of bio-actives, permeability enhancers, incorporation of advanced nano and microcarriers, and physical enhancement devices. This critical review summarizes the advancement in the chemical composition of bioactives used in skin cancer, such as sinecatechins, BIL-010t, patidegib, gingerol, curcumin, remetinostat, epigallocatechin-3-gallate, etc. Furthermore, this review, specifically addresses the progress in transdermal delivery systems for melanoma and non-melanoma cancer therapy, emphasizing advances in physical and chemical penetration enhancement and nanocarrier-assisted transdermal systems.
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Journal: Topical hedgehog inhibitors for basal cell carcinoma: how far away are we? (Pubmed Central) - Apr 7, 2022
Patidegib and itraconazole are two topical Hh inhibitors agents emerging as alternatives to oral Hh inhibiton for difficult-to-treat BCCs...Ongoing and recent clinical studies on topical Hedgehog inhibitors show great promise for the development of an agent with a high therapeutic index and limited adverse effects. If patidegib continues to show clinical efficacy in randomized controlled trials, it may become a universal therapy for all subtypes of difficult-to-treat BCC.
- || patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Review, Journal: Patidegib in Dermatology: A Current Review. (Pubmed Central) - Oct 28, 2021
Unlike systemic Hedgehog pathway inhibitors, patidegib 2% gel is not associated with systemic adverse effects and allows a better patient management. Considering the multidisciplinary management of neoplasia, in the era of precision medicine, it is mandatory to confide in pharmacogenomics to obtain personalized combined or sequential therapies.
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - Sep 9, 2021
P3, N=107, Terminated, Sponsor: PellePharm, Inc.
Considering the multidisciplinary management of neoplasia, in the era of precision medicine, it is mandatory to confide in pharmacogenomics to obtain personalized combined or sequential therapies. N=191 --> 107 | Trial completion date: Nov 2021 --> Jul 2021 | Enrolling by invitation --> Terminated | Trial primary completion date: Nov 2021 --> Jul 2021; Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%.
- ||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Trial termination: An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC (clinicaltrials.gov) - May 27, 2021
P2, N=47, Terminated, Sponsor: PellePharm, Inc.
N=191 --> 107 | Trial completion date: Nov 2021 --> Jul 2021 | Enrolling by invitation --> Terminated | Trial primary completion date: Nov 2021 --> Jul 2021; Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%. Active, not recruiting --> Terminated; Terminated early due to low blinded event rate
- ||||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Trial completion: Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome) (clinicaltrials.gov) - Mar 8, 2021
P3, N=174, Completed, Sponsor: PellePharm, Inc.
Active, not recruiting --> Terminated; Terminated early due to low blinded event rate Active, not recruiting --> Completed
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment closed: An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC (clinicaltrials.gov) - Mar 4, 2021
P2, N=47, Active, not recruiting, Sponsor: PellePharm, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- patidegib topical (IPI-926 topical) / Bridge Bio, Leo Pharma
[VIRTUAL] A Phase 1, Single-center, Pharmacokinetic, Safety and Tolerability Study of Patidegib Topical Gel in Healthy Adult Volunteers Under Maximum Use Conditions () - Oct 20, 2020 - Abstract #EADV2020EADV_1921;
- ||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment status: Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - Aug 23, 2020
P3, N=191, Enrolling by invitation, Sponsor: PellePharm, Inc.
Recruiting --> Active, not recruiting Recruiting --> Enrolling by invitation
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Trial primary completion date: An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC (clinicaltrials.gov) - Jul 20, 2020
P2, N=45, Recruiting, Sponsor: PellePharm, Inc.
Recruiting --> Enrolling by invitation Trial primary completion date: Jun 2020 --> May 2021
- |||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment open: Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - Jun 28, 2020
P3, N=191, Recruiting, Sponsor: PellePharm, Inc.
Trial primary completion date: Jun 2020 --> May 2021 Not yet recruiting --> Recruiting
- ||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Trial completion date, Trial primary completion date: Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome) (clinicaltrials.gov) - May 21, 2020
P3, N=174, Active, not recruiting, Sponsor: PellePharm, Inc.
Not yet recruiting --> Recruiting Trial completion date: May 2020 --> Dec 2020 | Trial primary completion date: May 2020 --> Dec 2020
- |||||||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
New P3 trial: Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - Mar 16, 2020
P3, N=191, Not yet recruiting, Sponsor: PellePharm, Inc.
- || patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment open: An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC (clinicaltrials.gov) - Dec 23, 2019
P2, N=45, Recruiting, Sponsor: PellePharm, Inc.
Trial completion date: May 2020 --> Dec 2020 | Trial primary completion date: May 2020 --> Dec 2020 Not yet recruiting --> Recruiting
- |||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment closed: Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome) (clinicaltrials.gov) - Dec 4, 2019
P3, N=174, Active, not recruiting, Sponsor: PellePharm, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
New P2 trial: An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC (clinicaltrials.gov) - Nov 14, 2019
P2, N=45, Not yet recruiting, Sponsor: PellePharm, Inc.
- |||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment open: Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome) (clinicaltrials.gov) - Feb 12, 2019
P3, N=150, Recruiting, Sponsor: PellePharm, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
New P3 trial: Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome) (clinicaltrials.gov) - Oct 10, 2018
P3, N=150, Not yet recruiting, Sponsor: PellePharm, Inc.
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Biomarker, Trial completion: Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas (clinicaltrials.gov) - Dec 4, 2017
P2, N=36, Completed, Sponsor: PellePharm, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Biomarker, Enrollment closed: Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas (clinicaltrials.gov) - Jul 25, 2017
P2, N=36, Active, not recruiting, Sponsor: PellePharm, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Biomarker, Trial primary completion date: Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas (clinicaltrials.gov) - May 12, 2017
P2, N=36, Recruiting, Sponsor: PellePharm, Inc.
Recruiting --> Active, not recruiting Trial primary completion date: May 2017 --> Sep 2017
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Trial completion: Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients (clinicaltrials.gov) - May 8, 2017
P2, N=17, Completed, Sponsor: PellePharm, Inc.
Trial primary completion date: May 2017 --> Sep 2017 Active, not recruiting --> Completed
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Biomarker, Enrollment open: Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas (clinicaltrials.gov) - Oct 31, 2016
P2, N=36, Recruiting, Sponsor: PellePharm, Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Enrollment closed, Trial primary completion date: Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients (clinicaltrials.gov) - Oct 31, 2016
P2, N=17, Active, not recruiting, Sponsor: PellePharm, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2016 --> May 2017
- patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Biomarker, New P2 trial: Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas (clinicaltrials.gov) - Jul 11, 2016
P2, N=36, Not yet recruiting, Sponsor: PellePharm, Inc.
- patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
New P2 trial: Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients (clinicaltrials.gov) - May 4, 2016
P2, N=18, Recruiting, Sponsor: PellePharm, Inc.