Tepilamide fumarate is under clinical development by Arbor Pharmaceuticals and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Tepilamide fumarate’s likelihood of approval (LoA) and phase transition for Plaque Psoriasis (Psoriasis Vulgaris) took place on 09 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Tepilamide fumarate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tepilamide fumarate overview

Tepilamide fumarate (XP-23829) is under development for the treatment of moderate to severe chronic plaque psoriasis. The drug candidate is administered orally in the form of tablet. XP-23829 is a new chemical entity and is a pro-drug of methylhydrogen fumarate (MHF), a fumaric acid monomethyl ester. The drug candidate is developed based on transported prodrug technology. The technology utilizes the body's natural mechanisms for actively transporting nutrients through cellular barriers. The drug candidate acts by targeting the mutated kelch like ECH associated protein 1 (KEAP1).

It was also under development for the treatment of patients with relapsing remitting multiple sclerosis (RRMS).

Arbor Pharmaceuticals overview

Arbor Pharmaceuticals (Arbor) is a specialty pharmaceutical company that offers prescription and generic products. The company offers medicines in the therapeutic areas of cardiology, pediatrics, and neuroscience, generics, and hospital and specialty markets. Its lead products under phase 3 stage include AR06, AR19 and AR25; and under phase 1 stage includes AR20. The company’s partnered products under phase1 stage include AR29 and AR30, and under phase 3 stage includes AR28. It also provides licensing, manufacturing, development and commercialization of late-stage prescription products. Arbor also develops both new chemical entities and already approved molecules for new indications or in improved dosage forms. It offers products, which are used in treatment areas such as cardiovascular, emergency, pediatrics, psychiatry, oncology, dermatology, urology, and endocrinology diseases. The company markets its products through sales professionals to hospitals and physicians across the US. Arbor is headquartered in Atlanta, Georgia, the US.

Quick View Tepilamide fumarate LOA Data

Report Segments
  • Innovator
Drug Name
  • Tepilamide fumarate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Immunology
Key Developers
  • Sponsor Company: Arbor Pharmaceuticals
  • Originator: XenoPort
Highest Development Stage
  • Phase II

GlobalData

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.