VivoSeq
Other

Intrahepatic Cholestasis

9

Pipeline Programs↗

6

Active Trials↗

7

Companies Involved↗

Intrahepatic Cholestasis is an early-stage landscape with 9 programs across 7 companies. The most active players are POLYSAN Scientific & Technological Pharmaceutical Company, Takeda, EMD Serono. 1 therapy is approved with 5 more in late-stage development.

Intelligence

Pipeline Metrics

Competitive Density

38/100

Pipeline Velocity

25/100

Mech. Concentration

50/100

Completion Rate

71/100

Attrition Rate

13/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved
Phase 3
Phase 2
Phase 1
Preclinical

Key Players

Top Companies Companies ranked by the number of pipeline programs they run for this disease.

P

POLYSAN Scientific & Technological Pharmaceutical Company

2 programs

Phase 3Takeda logo

Takeda

1 program

Phase 3EMD Serono logo

EMD Serono

1 program

Phase 3Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.

1 program

Phase 3M

Mirum Pharmaceuticals, Inc.

2 programs

Phase 3AbbVie logo

AbbVie

1 program

Approved

Pipeline

Programs by Phase

Analysis

Trial Status

16

clinical trials

Completed5 · 31%
Recruiting4 · 25%
Unknown status2 · 13%
Withdrawn1 · 6%
Approved for marketing1 · 6%
Not yet recruiting1 · 6%
Other2 · 13%

Clinical Trials

Trial Activity

16 trials

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
Recruiting·Takeda logoTakeda·N/A·NCT07293897·50 enrolled
Characterization of Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes in Adult Patients With Idiopathic Recurrent and Chronic Cholestasis in Spain - REGENIC
Recruiting·Ipsen logoIpsen·N/A·NCT07191704·150 enrolled
Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay).
Recruiting·Ipsen logoIpsen·N/A·NCT07588880·20 enrolled
Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay)
Recruiting·Ipsen logoIpsen·N/A·NCT07185919·10 enrolled
Analysis of the Effect of Odevixibat (A4250) Versus External Controls on Clinical Outcomes in Patients With PFIC (Odevixibat Versus External Control [OvEC]-PFIC)
Active, not recruiting·Ipsen logoIpsen·N/A·NCT07497724·200 enrolled
Maralixibat for Intrahepatic Cholestasis of Pregnancy
Not yet recruiting·IImperial College London·Phase 2·NCT07389031·28 enrolled
Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
Completed·PPOLYSAN Scientific & Technological Pharmaceutical Company·Phase 2/3·NCT06183242·328 enrolled
A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)
Completed·Takeda logoTakeda·Phase 3·NCT05543187·5 enrolled
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
Completed·MMirum Pharmaceuticals, Inc.·Phase 3·NCT03905330·93 enrolled
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Completed·TTurku University Hospital·Phase 3·NCT01576458·20 enrolled
An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Completed·MMirum Pharmaceuticals, Inc.·Phase 3·NCT04185363·84 enrolled
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Terminated·MMirum Pharmaceuticals, Inc.·Phase 2·NCT04718961·4 enrolled
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Withdrawn·MMirum Pharmaceuticals, Inc.·Phase 3·NCT03353454
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
Approved for marketing·AAlbireo·N/A·NCT04483531
Metformin in Intrahepatic Cholestasis of Pregnancy
Unknown status·—·Phase 2/3·NCT03056274·40 enrolled
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Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)