Product Description
Xevinapant (formerly known as Debio 1143) is an investigational potent oral small-molecule IAP (inhibitor of apoptosis protein) inhibitor. In March 2021, Merck KGaA, Darmstadt, Germany, gained exclusive rights from Debiopharm International SA to develop and commercialize xevinapant worldwide. Xevinapant is not approved for any use anywhere in the world. (Sourced from: https://www.emdserono.com/us-en/company/news/press-releases/update-on-xevinapant-program-2024-highlights-24-06-2024.html)
Mechanisms of Action: IAP Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Head and Neck Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Debiopharm
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, United Kingdom, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Head and Neck Cancer|Squamous Cell Carcinoma
Phase 2: Oncology Solid Tumor Unspecified
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06110195 |
IRB23-0294 | P1 |
Active, not recruiting |
Squamous Cell Carcinoma|Head and Neck Cancer |
2027-10-01 |
50% |
2024-06-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2018-003546-16 |
SMARTPLUS-106 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2024-01-21 |
12% |
2022-03-13 |
Treatments |
NCT05519540 |
MS202359_0004 | P1 |
Completed |
Healthy Volunteers |
2023-04-21 |
88% |
2025-08-21 |
|
NCT05724602 |
RAVINA | P2 |
Suspended |
Squamous Cell Carcinoma|Head and Neck Cancer |
2029-07-01 |
44% |
2024-08-28 |
Primary Endpoints|Treatments|Trial Status |
2020-000377-25 |
TrilynX | P3 |
Completed |
Squamous Cell Carcinoma|Head and Neck Cancer |
2024-09-18 |
3% |
2025-07-09 |
Treatments |
2023-508528-36-00 |
MS202359_0002 | P3 |
Completed |
Squamous Cell Carcinoma|Head and Neck Cancer |
2024-08-27 |
2025-05-02 |
Treatments |