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Elafibranor - Phase 3 | IPSEY Pipeline | CatalystAlert

Elafibranor

Phase 3

Ipsen Biopharmaceuticals, Inc. (IPSEY)

00%

Phase 3

Development Phase

2

Upcoming Catalysts

1

Historical Events

1

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

9mo

IPSEYPhase 3$16.2B

Elafibranor Phase 3 Results Expected

Elafibranor• Primary Biliary Cholangitis18

Dec 17Estimated

00%

3mo

IPSEYPhase 3$16.2B

Elafibranor Phase 3 Results Expected

Elafibranor• Primary Biliary Cholangitis69

Jun 26Estimated

00%

Development History

Past

days

IPSEYPhase 3$16.2B

Elafibranor Phase 3 Results Expected

Elafibranor• Primary Biliary Cholangitis18

Mar 19Estimated

00%

Competitive Landscape

2 competitors in Primary Biliary Cholangitis

ENTAEDP-305 1 mg

View Full Landscape

Drug Information

Target Indication

Primary Biliary Cholangitis

Clinical Trial

Last updated: 1/2/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA9/19/2024

Iqirvo

Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

OrphanConditional

Drug Science

Mechanism of action & safety profile

Developer

IPSEY

Ipsen Biopharmaceuticals, Inc.

Healthcare•North America•NASDAQ

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lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose intervalPhase 3

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