Seladelpar

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Liver TransplantPrimary Biliary Cholangitis

96 competitors in Liver Transplant

#DrugCompanyPhaseTrials

1

Giapreza

LLa Jolla Pharmaceutical Company

Phase 3

12

Prothrombin Complex Concentrate

CSL Behring

Phase 3

13

Darbepoetin

Bayer

Phase 3

14

Rezzayo

MMundipharma (China) Pharmaceutical Co. Ltd

Phase 3

15

Seladelpar

Gilead

Phase 3

16

Tacrolimus Pill

EEdward Geissler

Phase 3

17

Lenvima

Eisai

Preclinical

28

Octreotide

Johnson & Johnson

Preclinical

29

Beyfortus

BeiGene

Preclinical

110

Prostigmin

Merck & Co.

Preclinical

1Show 34 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

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

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

Show 3 more trials

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

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

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·NCT06051617·402 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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