Product Description
Ponesimod is an orally active, selective S1P1R modulator that causes dose-dependent sequestration of lymphocytes in lymphoid organs. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/26770667/)
Mechanisms of Action: S1P1 Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Canada | Chile | Croatia | Czech | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Italy | Korea | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Serbia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belarus, Belgium, Bosnia, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| PIONEER | P3 |
Active, not recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2027-10-27 |
2025-05-06 |
Treatments |
|
| OPTIMUM-LT | P3 |
Completed |
Multiple Sclerosis |
2024-01-16 |
34% |
2024-02-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| OPTIMUM LT | P3 |
Active, not recruiting |
Multiple Sclerosis |
2024-01-04 |
34% |
2025-05-06 |
Treatments |
| 2009-011470-15 | P2 |
Completed |
Multiple Sclerosis, Relapsing-Remitting |
2023-09-06 |
59% |
2025-06-14 |
Treatments |
| AC-058B202 | P2 |
Completed |
Multiple Sclerosis, Relapsing-Remitting |
2023-09-06 |
59% |
2023-10-13 |
Primary Endpoints|Treatments|Trial Status |
| CR109254 | P1 |
Completed |
Healthy Volunteers |
2023-03-05 |
69% |
2023-04-15 |
Primary Endpoints |