Last reviewed · How we verify
Imigran
Imigran is a Small molecule drug developed by Danish Headache Center. It is currently in Phase 1 development. Also known as: Sumatriptan.
-
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 | Imigran |
|---|---|
| Also known as | Sumatriptan |
| Sponsor | Danish Headache Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department (NA)
- Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section (NA)
- Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents (PHASE3)
- Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine (PHASE2)
- A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System (PHASE1)
- Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002) (PHASE1)
- Sumatriptan as Treatment for Post-traumatic Headache (PHASE2)
- Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache (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:
- Imigran CI brief — competitive landscape report
- Imigran updates RSS · CI watch RSS
- Danish Headache Center portfolio CI
Frequently asked questions about Imigran
What is Imigran?
Who makes Imigran?
Is Imigran also known as anything else?
What development phase is Imigran in?
Related
- Manufacturer: Danish Headache Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Sumatriptan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing