Last reviewed · How we verify
gepants
gepants is a Small molecule drug developed by IRCCS San Raffaele Roma. It is currently in Phase 2 development.
Gepants are a class of drugs that act as antagonists of the calcitonin gene-related peptide receptor (CGRPR). They are used to treat various types of migraines, including Migraine With Aura, Migraine Without Aura, Chronic Migraine, Episodic Migraine, and are studied as acute treatments in clinical trials such as NCT05903027.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | gepants |
|---|---|
| Sponsor | IRCCS San Raffaele Roma |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications (PHASE4)
- Gepant treAtments: EffectIveNess and tolERability (GAINER)
- Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients
- RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
- Chinese Real-world Study of Treatment of Vestibular Migraine
- Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
- i-NEED: NEw migrainE Drugs Database
- Acute Migraine Treatment in the ED With Gepants (PHASE4)
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:
- gepants CI brief — competitive landscape report
- gepants updates RSS · CI watch RSS
- IRCCS San Raffaele Roma portfolio CI
Frequently asked questions about gepants
What is gepants?
Who makes gepants?
What development phase is gepants in?
Related
- Manufacturer: IRCCS San Raffaele Roma — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing