patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma, Infinity Pharma - LARVOL DELTA

Phase 2 Trial of Topical Application of the Hedgehog Inhibitor Patidegib in Patients With Gorlin Syndrome. (PubMed, Br J Dermatol) - "Patidegib Topical Gel warrants further clinical development."

Journal • P2 data • Basal Cell Carcinoma • Oncology • PTCH1

A phase 3, randomized controlled trial of topical patidegib gel 2% in patients with Gorlin syndrome (EADV 2024) - "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"

Clinical • Late-breaking abstract • P3 data • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • PTCH1

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Sol-Gel Technologies, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • PTCH1

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome (clinicaltrials.gov) - P3 | N=140 | Not yet recruiting | Sponsor: Sol-Gel Technologies, Ltd.

New P3 trial • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • PTCH1

Topical Delivery of Hedgehog Inhibitors: Current Status and Perspectives. (PubMed, Int J Mol Sci) - "Murine studies showed that the topical delivery of sonidegib, itraconazole, vitamin D₃ and CUR-61414 led to biological responses and tumor remission. 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."

Journal • Review • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Recent advances in chemical composition and transdermal delivery systems for topical bio-actives in skin cancer. (PubMed, Curr Top Med Chem) - "The most commonly used topical agents for treating skin carcinoma are- 5-fluorouracil, imiquimod, sonidegib, dacarbazine, etc. However, drug physicochemical characteristics and skin physiological barriers limit the anticancer potency of topical as well as transdermal drug delivery. 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."

Journal • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Topical hedgehog inhibitors for basal cell carcinoma: how far away are we? (PubMed, Expert Opin Pharmacother) - "These agents such as vismodegib and sonidegib are associated with short-lived responses as well as significant adverse effects including myalgias, dysgeusia, and alopecia. 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."

Journal • Alopecia • Basal Cell Carcinoma • Musculoskeletal Pain • Non-melanoma Skin Cancer • Oncology • Pain • Solid Organ Transplantation • Transplantation

Patidegib in Dermatology: A Current Review. (PubMed, Int J Mol Sci) - "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."

Journal • Review • Basal Cell Carcinoma • Dermatology • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor

Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - P3; N=107; 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%.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Rare Diseases

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) - P2; N=47; Terminated; Sponsor: PellePharm, Inc.; Active, not recruiting ➔ Terminated; Terminated early due to low blinded event rate

Clinical • Trial termination • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

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) - P3; N=150; Not yet recruiting; Sponsor: PellePharm, Inc.

Clinical • New P3 trial • Basal Cell Carcinoma • Oncology • Solid Tumor • PTCH1

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) - P3; N=174; Active, not recruiting; Sponsor: PellePharm, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Basal Cell Carcinoma • Oncology • Solid Tumor • PTCH1

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) - P3; N=150; Recruiting; Sponsor: PellePharm, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Basal Cell Carcinoma • Oncology • Solid Tumor • PTCH1

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) - P3; N=174; Completed; Sponsor: PellePharm, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Basal Cell Carcinoma • Oncology • PTCH1

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) - P3; N=174; Active, not recruiting; Sponsor: PellePharm, Inc.; Trial completion date: May 2020 ➔ Dec 2020; Trial primary completion date: May 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Oncology • Solid Tumor • PTCH1

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) - P2; N=47; Active, not recruiting; Sponsor: PellePharm, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

[VIRTUAL] A Phase 1, Single-center, Pharmacokinetic, Safety and Tolerability Study of Patidegib Topical Gel in Healthy Adult Volunteers Under Maximum Use Conditions (EADV 2020) - No abstract available

Clinical • P1 data • PK/PD data

Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - P3; N=191; Enrolling by invitation; Sponsor: PellePharm, Inc.; Recruiting ➔ Enrolling by invitation

Enrollment status

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) - P2; N=45; Recruiting; Sponsor: PellePharm, Inc.; Trial primary completion date: Jun 2020 ➔ May 2021

Clinical • Trial primary completion date • Basal Cell Carcinoma • Oncology

Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - P3; N=191; Recruiting; Sponsor: PellePharm, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Phase 3, Multicenter, unblinded Extension Study of Patidegib Topical Gel, 2% in patient with Gorlin Syndrome Estudio de fase III, multicéntrico, abierto y de ampliación con patidegib gel tópico al 2% en pacientes con síndrome de Gorlin (clinicaltrialsregister.eu) - P3; N=200; Ongoing; Sponsor: PellePharm, Inc.

Clinical • New P3 trial • Basal Cell Carcinoma • Genetic Disorders • Oncology • Solid Tumor

Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) (clinicaltrials.gov) - P3; N=191; Not yet recruiting; Sponsor: PellePharm, Inc.

Clinical • New P3 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) - P2; N=45; Recruiting; Sponsor: PellePharm, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open