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Sumatriptan clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our Canada, Mexico and Egypt registers that name Sumatriptan as an intervention. Synced 4 Oct 2026
2Current trials
2Recruiting now
2Lead sponsors
3Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov registry records · Last verified · Editorial standards
At a glance

Sumatriptan is named as an intervention in 2 current clinical trials in our Canada, Mexico and Egypt registers. 2 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Duke University (1). The most-studied condition is Lactating Women on Select DOI. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Sumatriptan is approved

All regulators →

Of the three regulators tracked here, the first to approve Sumatriptan was the US, on 28 Dec 1992.

USUnited States (FDA)
28 Dec 1992
Imitrex Statdose (autoinjector)
NDA020080 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Sumatriptan patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Sumatriptan, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Imitrex Statdose, Onzetra Xsail, Zembrace Symtouch
  • 20 listed patents; the last listed expires 29 Jan 2036 (US 10537554).
See the Orange Book listing for NDA 020080
Patents and exclusivities above are pooled across 6 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Sumatriptan

All medicines →
ENNHS England
£33.4m
2,710,483 items dispensed, Aug 2025 to Jul 2026
+31% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$34.0m
1,566,529 prescriptions in 2025 · Sumatriptan Succinate, Sumatriptan, Sumatriptan
+3% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

Patient leaflets for Sumatriptan

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting2100%

Trials by phase

  • Observational150%
  • Not applicable150%
01

Clinical trials of Sumatriptan

2 trials
StudyPhaseStatusLead sponsorRegisters

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Sumatriptan in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Sumatriptan. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
The headache- and migraine-inducing effects of pitolisant in women with migraine without aura
2026-525521-20-00 · CTIS ↗ · Nervous System Diseases
Phase 1 Authorised Syddansk Universitet (University of Southern Denmark) Denmark
03

Sumatriptan across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

11 single-substance products containing Sumatriptan on the HPRA medicines list.

All 11 Irish products →

Supply shortages

  • Sumatriptan Aurobindo 100 mg TablettenGermany (BfArM) · Production problem · 6 Jul 2026 to 30 Oct 2026
04

Conditions studied with Sumatriptan

6 conditions
Lactating Women on Select DOI1Breastfed Infants of Mothers on Select DOI1Theophylline1Sumatriptan1Gabapentin1Post-Dural Puncture Headache1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Duke University1
Tanta University1
06

By country register

RegisterTrialsRecruiting
Clinical trials in Canada11
Clinical trials in Mexico11
Clinical trials in Egypt11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Sumatriptan trials

How many clinical trials are testing Sumatriptan?

2 current trials in our Canada, Mexico and Egypt registers name Sumatriptan as a drug or biological intervention, as of the registry sync on 4 October 2026. Completed and withdrawn studies are not counted.

Are Sumatriptan trials recruiting patients?

Yes. 2 of the 2 trials are recruiting: 1 with sites in Canada, 1 with sites in Mexico and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Sumatriptan clinical trials?

Duke University (1) and Tanta University (1). The number in brackets is how many trials each organisation leads.

Is Sumatriptan licensed in Ireland?

Yes. The HPRA medicines list includes 11 single-substance products containing Sumatriptan, for example Imigran 10 mg Nasal Spray, Solution (GlaxoSmithKline (Ireland) Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Sumatriptan shortage?

The registers we track list 1 entry for Sumatriptan: 1 German notice. Shortages are product- and country-specific; check with a pharmacist.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Sumatriptan works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Sumatriptan works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Sumatriptan (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 4 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.