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NP101
NP101 is a selective serotonin 5-HT1F receptor agonist that reduces migraine pain by constricting cranial blood vessels and inhibiting neuropeptide release.
NP101 is a selective serotonin 5-HT1F receptor agonist that reduces migraine pain by constricting cranial blood vessels and inhibiting neuropeptide release. Used for Acute migraine with or without aura.
At a glance
| Generic name | NP101 |
|---|---|
| Sponsor | NuPathe Inc. |
| Drug class | 5-HT1F receptor agonist |
| Target | 5-HT1F receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
NP101 selectively binds to 5-HT1F receptors on trigeminal nerve terminals and cranial blood vessels, leading to vasoconstriction and suppression of pain-signaling neuropeptide release. This mechanism is distinct from traditional triptans, which target multiple serotonin receptors, potentially offering improved tolerability and efficacy in acute migraine treatment.
Approved indications
- Acute migraine with or without aura
Common side effects
- Dizziness
- Somnolence
- Nausea
- Paresthesia
Key clinical trials
- Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors (PHASE1)
- Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (PHASE1)
- NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas (PHASE1)
- Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (PHASE2)
- Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults (PHASE1)
- An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months (PHASE3)
- An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months (PHASE3)
- The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (PHASE3)
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:
- NP101 CI brief — competitive landscape report
- NP101 updates RSS · CI watch RSS
- NuPathe Inc. portfolio CI