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Ponesimod 80 mg
Ponesimod 80 mg is a Small molecule drug developed by Actelion. It is currently in Phase 1 development. Also known as: ACT-128800.
Ponesimod 80 mg is a small molecule that acts as an agonist of the Sphingosine 1-phosphate receptor 1. It is classified as a drug that has been studied for its safety and tolerability in healthy subjects.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ponesimod 80 mg |
|---|---|
| Also known as | ACT-128800 |
| Sponsor | Actelion |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State (PHASE1)
- Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects (PHASE1)
- Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ponesimod 80 mg CI brief — competitive landscape report
- Ponesimod 80 mg updates RSS · CI watch RSS
- Actelion portfolio CI
Frequently asked questions about Ponesimod 80 mg
What is Ponesimod 80 mg?
Who makes Ponesimod 80 mg?
Is Ponesimod 80 mg also known as anything else?
What development phase is Ponesimod 80 mg in?
Related
- Manufacturer: Actelion — full pipeline
- Also known as: ACT-128800
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing