Drugs / Sumatriptan
last change Nov 2025 re-read 8 days ago

Sumatriptan

also known as sumatriptan succinate · Imitrex · NP101 · Imigran · DFN-11 · Alsuma() · DFN-02 · Omexa · +2 more
Developed for
migraine disorder · cluster headache syndrome · intracranial hypotension · migraine without aura · alcohol-induced mental disorder · headache disorder · migraine with aura · rosacea
+1 more · traumatic encephalopathy
Investigated by
GlaxoSmithKline · NuPathe Inc. · Dr. Reddy's Laboratories Limited · Alder Biopharmaceuticals, Inc. · Eli Lilly and Company · Mylan Pharmaceuticals Inc
+47 more · POZEN · Pfizer · Viatris Inc. · Zogenix, Inc. · American Regent, Inc. · Amgen · Beijing Friendship Hospital · Bispebjerg Hospital · Cady, Roger, M.D. · Cambridge University Hospitals NHS Foundation Trust · Charleston Laboratories, Inc · CoLucid Pharmaceuticals · Currax Pharmaceuticals · Danish Headache Center · Diamond Headache Clinic · Gitte Moos Knudsen · Glostrup University Hospital, Copenhagen · H. Lundbeck A/S · Isfahan University of Medical Sciences · Jiangsu Provincial People's Hospital · Johns Hopkins University · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Merck Sharp & Dohme LLC · Montefiore Medical Center · Optinose US Inc. · Organon and Co · Peking University Third Hospital · Premiere Research Institute · SNBL Clinical Pharmacology Center, Inc. · Second Affiliated Hospital of Wenzhou Medical University · Second Hospital of Jilin University · SoluBest Ltd. · Synteract, Inc. · Tanta University · Targia Pharmaceuticals Ltd. · Teva Pharmaceuticals USA · The Affiliated Hospital of Qingdao University · The First Affiliated Hospital of Guangzhou Medical University · The Second Affiliated Hospital of Kunming Medical University · The Second Hospital of Nanjing Medical University · The Third Xiangya Hospital of Central South University · Universitaire Ziekenhuizen KU Leuven · University Health Network, Toronto · University Medical Center Goettingen · University of Washington · Upsher-Smith Laboratories · West China Hospital

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) ZEMBRACE SYMTOUCH — 2019-06-10 fda.gov ↗
Label expansion US (FDA) SUMAVEL DOSEPRO — 2013-11-26 fda.gov ↗
Refused (EMA) EU (EMA) Sumatriptan Galpharm — 2012-02-09 europa.eu ↗
Label expansions (2) US (FDA) IMITREX STATDOSE — 1996-05-22 – 2006-02-01 fda.gov ↗
Label expansions (2) US (FDA) IMITREX — 1998-02-13 – 2004-10-13 fda.gov ↗
Approved US (FDA) IMITREX STATDOSE — 1992-12-28 fda.gov ↗

Trials 60

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04690270 Jan → Jun 2021 obesity disorder Cambridge University Hospitals NHS Foundation Trust Unknown No outcome recorded
Phase 120 trials · 1 met primary
Phase 1 NCT05064488 Oct → Dec 2021 — Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT04355845 Jun → Aug 2020 — Pfizer Completed No outcome recorded
Phase 1 NCT04197349 Sep 2019 → Aug 2020 migraine disorder H. Lundbeck A/S Completed No outcome recorded
Phase 1 NCT03310411 Oct → Dec 2017 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT03076970 Mar → Apr 2017 migraine disorder Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02932488 Sep 2016 → Jun 2019 — Gitte Moos Knudsen Terminated No outcome recorded
Phase 1 NCT02954276 Mar → Aug 2016 migraine disorder Targia Pharmaceuticals Ltd. Unknown No outcome recorded
Phase 1 NCT02741310 Feb → Aug 2016 — Amgen Completed No outcome recorded
Phase 1 NCT02684409 Aug 2013 → Nov 2014 migraine disorder NuPathe Inc. Completed No outcome recorded
Phase 1 NCT02054299 Apr 2013 → Feb 2016 — University Medical Center Goettingen Completed No outcome recorded
Phase 25 trials · 1 met primary · 2 missed
Phase 2 NCT03877718 Feb → Aug 2019 migraine disorder Charleston Laboratories, Inc Completed No outcome recorded
Phase 2 NCT02856802 Jul 2016 → Feb 2017 migraine disorder Upsher-Smith Laboratories Completed Met primary
Phase 2 NCT02571049 Sep 2015 → Apr 2016 migraine disorder Dr. Reddy's Laboratories Limited Completed Missed primary
Phase 2 NCT01854385 Jun 2013 → Feb 2018 — University of Washington Completed Missed primary
Phase 2 NCT01791400 Jul 2009 → Nov 2010 migraine disorder Isfahan University of Medical Sciences Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01016678 Mar 2010 → Jun 2014 migraine disorder Premiere Research Institute Completed Mixed
Phase 323 trials · 8 met primary · 1 missed
Phase 3 NCT04948164 Aug 2018 → Dec 2021 migraine disorder Peking University Third Hospital Unknown No outcome recorded
Phase 3 NCT03338920 Nov 2017 → Apr 2022 migraine disorder Currax Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT02569853 Sep 2015 → May 2017 migraine disorder Dr. Reddy's Laboratories Limited Completed Met primary
Phase 3 NCT02279082 Sep 2014 → Sep 2015 migraine disorder Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 3 NCT00806546 Feb 2009 → May 2011 migraine disorder NuPathe Inc. Completed No outcome recorded
Phase 3 NCT00792103 Jan 2009 → Sep 2010 migraine disorder NuPathe Inc. Completed No outcome recorded
Phase 3 NCT00724815 Jan → Jul 2009 migraine disorder NuPathe Inc. Completed Met primary
Phase 3 NCT00843024 Dec 2008 → May 2010 migraine disorder GlaxoSmithKline Completed Met primary
Phase 3 NCT00573170 Feb 2008 → Aug 2009 migraine disorder GlaxoSmithKline Completed Missed primary
Phase 3 NCT00488514 Jul 2007 → Aug 2009 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 46 trials · 2 met primary
Phase 4 NCT01807234 Feb 2013 → Dec 2014 migraine disorder Johns Hopkins University Completed Met primary
Phase 4 NCT01071317 Feb 2010 → Jan 2012 migraine disorder Montefiore Medical Center Completed No outcome recorded
Phase 4 NCT01016834 Nov 2009 → Apr 2010 migraine disorder Zogenix, Inc. Completed Met primary
Phase 4 NCT00893737 Jun 2009 → Jan 2010 migraine disorder Cady, Roger, M.D. Completed No outcome recorded
Phase 4 NCT00792636 Nov 2008 → Nov 2009 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT00399243 Nov 2006 → Aug 2010 cluster headache syndrome Diamond Headache Clinic Unknown No outcome recorded
Phase not applicable4 trials · 1 met primary
— NCT07515456 Dec 2024 → Nov 2026 expected intracranial hypotension Tanta University Recruiting No outcome recorded
— NCT05654298 Mar 2022 → Mar 2023 migraine disorder Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
— NCT01632657 Jun 2012 → Oct 2019 — University Health Network, Toronto Completed Met primary
— NCT00399633 Jan → Apr 2007 migraine disorder Danish Headache Center Completed No outcome recorded
Comparator or background therapy49 trials
Phase 1 NCT03229798 Comparator Jan → Mar 2018 migraine disorder Sorrento Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT00989625 Comparator Nov 2008 → Sep 2009 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00875784 Comparator May → Jun 2008 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00546650 Comparator Nov → Dec 2007 — NuPathe Inc. Completed No outcome recorded
Phase 1 NCT00846885 Comparator Aug → Sep 2004 — Teva Pharmaceuticals USA Completed No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2025-11-01 Alembic Pharmaceuticals Ltd. Regulatory 07th November, 2025 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System.
2011-06-21 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma announces USFDA approval for generic Imitrex® injection sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Sumatriptan Succinate Injection, 6 mg (base) / 0.5mL.
2009-08-11 Sun Pharmaceutical Industries, Inc. Regulatory Generic Eloxatin® and Imitrex® approval: shares 180-day marketing drug exclusivity for generic Eloxatin® sunpharma.com ↗
2009-02-17 Wockhardt Regulatory Wockhardt to launch generic version of migraine drug Sumatriptan in the US market wockhardt.com ↗
Wockhardt received the final appr oval from the United States Food & Drug Administration (US FDA) for marketing the injections containing 6mg per 0.5ml Sumatriptan succinate, which is used for treating migraine headaches.
2009-02-11 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval and Launch of Generic Imitrex® Tablets tevapharm.com ↗
the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's Imitrex® Tablets, 25 mg, 50 mg and 100 mg
2006-11-29 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval Of Sumatriptan Succinate Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg, 50 mg and 100 mg.

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 112 sources stand behind the page.

FieldValueCited text
Known as Sumatriptan “This randomized, open-label, 3-period crossover study compared the exposure to sumatriptan (Cmax and AUC to 14 hours after the administration of the second dose [AUC(0-14)])...” PMID 20637969 ↗ Jun 2010
100

“The choice of triptans (rizatriptan®, sumatriptan®), the route(s) of triptan administration (oral, nasal spray, subcutaneous injection), and the addition of a NSAID, or...” NCT00910689 ↗

“Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.” NCT00806546 ↗

“One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.” NCT01138150 ↗

“BACKGROUND: DFN-11, a 3 mg sumatriptan subcutaneous (SC) autoinjector for acute treatment of migraine, has not been assessed previously in multiple attacks.” PMID 30112725 ↗ Aug 2018

“One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.” NCT02176655 ↗

“Treximet(tm) is a triptan tablet containing a combination of sumatriptan 85mg (Imitrex) and naproxen sodium 500 mg.” NCT01450995 ↗

“ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents” NCT01016678 ↗

“NP101, a transdermal sumatriptan formulation in development for the acute treatment of migraine” PMID 22352764 ↗ Feb 2012

“with sumatriptan-naproxen (Treximet®) or placebo in a double-blind, placebo-controlled fashion” PMID 23406052 ↗ Feb 2013

“Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine” NCT06617832 ↗

Show 90 more sources

Known as Alsuma() “a novel sumatriptan auto-injector (Alsuma(®)), and to evaluate the safety, tolerability, and effectiveness of this sumatriptan auto-injector during an acute migraine attack.” PMID 23148799 ↗ Nov 2012
Known as DFN-02 “A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.” NCT02856802 ↗
Known as DFN-11 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02569853 ↗
1

NCT02571049 ↗

Known as Imigran “Sumatriptan (Imigran) is a selective serotonin receptor agonist. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and...” NCT06514040 ↗
2

NCT03881644 ↗

NCT03878784 ↗

Known as Imitrex “the trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal...” NCT02954276 ↗
8

“This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of...” NCT03076970 ↗

“IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System®” NCT00875784 ↗

“20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray” NCT01507610 ↗

“100 mg oral tablet commercial Imitrex sumatriptan succinate tablet” NCT03229798 ↗

“Sumatriptan succinate (Imitrex®) tablet: 100 mg orally.” NCT00546650 ↗

NCT01450995 ↗

NCT00846885 ↗

NCT00573599 ↗

Known as NP101 “A Phase I, Open Label, Single-Dose, Four-Way Crossover Study Comparing the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of...” NCT00723983 ↗
6

“Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.” NCT00806546 ↗

“A Phase I, Single Center, Open Label, Single-Dose, Five-Period Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) in Healthy Volunteers” NCT00720018 ↗

“OBJECTIVE: To assess the long-term tolerability and efficacy of NP101, a novel transdermal sumatriptan patch being developed for the acute treatment of migraine.” PMID 22352764 ↗ Feb 2012

“Two NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex” NCT01381796 ↗

“NP101 (Sumatriptan Iontophoretic Transdermal Patch)” NCT00546650 ↗

“NP101 - sumatriptan iontophoretic transdermal patch” NCT00724815 ↗

Known as Omexa “the trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal...” NCT02954276 ↗
Known as OPTINOSE SUMATRIPTAN “20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray” NCT01507610 ↗
Known as sumatriptan succinate “Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.” NCT00806546 ↗
12

“Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer” NCT00383162 ↗

“fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg” NCT00573170 ↗

“IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System®” NCT00875784 ↗

“One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)” NCT03877718 ↗

“Combination Product (sumatriptan succinate / naproxen sodium)” NCT00385008 ↗

“Sumatriptan succinate (Imitrex®) tablet: 100 mg orally.” NCT00546650 ↗

“Treatment C - oral sumatriptan succinate” NCT01381796 ↗

“Sumatriptan Succinate Tablets 100 mg” NCT00648466 ↗

“sumatriptan succinate 100 mg” NCT00920686 ↗

NCT03229798 ↗

Show 2 more sources

Known as Sumigran 25 “Patients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours.” NCT07515456 ↗
Action Activate “The receptor can be stimulated with the agonist sumatriptan” NCT02932488 ↗
Route Oral “sumatriptan succinate/naproxen sodium) tablets vs placebo” NCT00329355 ↗