Isotretinoin is under clinical development by Timber Pharmaceuticals and currently in Phase III for Harlequin Ichthyosis (Autosomal Recessive Congenital Ichthyosis 4B). According to GlobalData, Phase III drugs for Harlequin Ichthyosis (Autosomal Recessive Congenital Ichthyosis 4B) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Isotretinoin LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Isotretinoin overview

Isotretinoin (PAT-001) is under development for the treatment of moderate to severe congenital ichthyosis and X-linked recessive ichthyosis (XLRI). The drug candidate is formulated as a ointment and is administered through topical route. It acts by targeting retinoic acid receptor (RAR).

It was also under development for Darier’s disease, severe acne and sebaceous hyperplasia.

Timber Pharmaceuticals overview

Timber Pharmaceuticals is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of treatments for orphan dermatologic diseases. It is also focused on developing non-systemic treatments for rare dermatologic diseases, including congenital ichthyosis (CI), facial angiofibromas (FAs) in the tuberous sclerosis complex (TSC), and sclerotic skin diseases. Its lead mid to late-stage programs are TMB-001 and TMB-002. TMB-003 is its earliest stage program. TMB-001 is a topical formulation of isotretinoin using its IPEG delivery system, completed its Phase IIb clinical trials for the treatment of moderate to severe subtypes of CI. TMB-002 is a topical formulation of rapamycin, which is being evaluated in a Phase IIb clinical trial for the treatment of FAs in TSC. TMB-003 is a formulation of Sitaxsentan, which is a selective endothelin-A receptor antagonist for the treatment of sclerotic skin diseases.It is headquartered in Basking Ridge, New Jersey, United States.

For a complete picture of Isotretinoin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.