Seladelpar

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Liver TransplantHepatitisPrimary Biliary Cholangitis

353 competitors in Liver Transplant

#DrugCompanyPhaseTrials

1

Seladelpar

Gilead

Phase 3

12

Cysteine Hydrochloride

Novartis

Preclinical

33

Octreotide

Johnson & Johnson

Preclinical

24

Lenvima

Eisai

Preclinical

25

Myfortic

Novartis

Preclinical

16

Beyfortus

BeiGene

Preclinical

17

Prostigmin

Merck & Co.

Preclinical

18

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

49

Myfortic

Novartis

Preclinical

610

Cyklokapron

AAmring

Preclinical

2Show 23 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Primary Biliary Cholangitis6 trials

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

Active, not recruiting·Gilead·Phase 3·NCT03301506·500 enrolled

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Completed·Gilead·Phase 3·NCT04620733·193 enrolled

Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Active, not recruiting·Gilead·Phase 3·NCT06060665·90 enrolled

Show 3 more trials

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Completed·Gilead·Phase 3·NCT03602560·265 enrolled

An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Completed·Gilead·Phase 1·NCT04950764·24 enrolled

AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Recruiting·Gilead·Phase 3·NCT06051617·318 enrolled

Hepatitis1 trial

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Terminated·Gilead·Phase 2·NCT03551522·181 enrolled

Efficacy1 trial

A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

Terminated·Gilead·Phase 2·NCT04024813·1 enrolled

Hepatic Impairment1 trial

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

Completed·Gilead·Phase 1·NCT03369002·32 enrolled

Liver Transplant1 trial

A Prospective, Open-label, Single-arm, Investigator-initiated Study (SELIC) to Evaluate the Efficacy and Safety of Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (IC).

Not yet recruiting·UUniversity of California, San Diego··NCT07305363·10 enrolled

Details

Drug Info

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