Drugs / Sumatriptan
last change Aug 2025 re-read 2 minutes 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 · a red edge is where a trial was stopped

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
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
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 No outcome recorded
Phase 2 NCT02571049 Sep 2015 → Apr 2016 migraine disorder Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 2 NCT01854385 Jun 2013 → Feb 2018 University of Washington Completed No outcome recorded
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 No outcome recorded
Phase 323 trials
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 No outcome recorded
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 No outcome recorded
Phase 3 NCT00843024 Dec 2008 → May 2010 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00573170 Feb 2008 → Aug 2009 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00488514 Jul 2007 → Aug 2009 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 46 trials
Phase 4 NCT01807234 Feb 2013 → Dec 2014 migraine disorder Johns Hopkins University Completed No outcome recorded
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 No outcome recorded
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
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 No outcome recorded
NCT00399633 Jan → Apr 2007 migraine disorder Danish Headache Center Completed No outcome recorded
Also used as a comparator or background therapy in 49 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 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
Phase 25 trials
Phase 2 NCT02176655 Comparator Jul 2014 → Jan 2016 alcohol-induced mental disorder Cady, Roger, M.D. Completed No outcome recorded
Phase 2 NCT01430442 Comparator Oct 2011 → May 2012 migraine disorder Pfizer Completed No outcome recorded
Phase 2 NCT00920686 Comparator Jun 2009 → Mar 2010 migraine with aura NeurAxon Inc. Completed No outcome recorded
Phase 2 NCT00892203 Comparator Apr 2009 → Aug 2010 migraine disorder Novartis Completed No outcome recorded
Phase 2 NCT00804973 Comparator Nov 2008 → May 2009 migraine disorder Eli Lilly and Company Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03185143 Comparator Jun 2017 → May 2018 migraine disorder Allodynic Therapeutics, Inc Completed No outcome recorded
Phase 39 trials
Phase 3 NCT01814189 Comparator Jan → Apr 2013 migraine with aura, migraine without aura Shahid Beheshti University of Medical Sciences Completed No outcome recorded
Phase 3 NCT01667679 Comparator Aug 2012 → Mar 2014 migraine disorder Avanir Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01462812 Comparator Jan 2011 → Jun 2012 migraine disorder Optinose US Inc. Completed No outcome recorded
Phase 3 NCT00963937 Comparator Sep 2009 → Dec 2010 migraine disorder GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00894556 Background Jun 2009 → Jan 2010 migraine disorder Organon and Co Completed No outcome recorded
Phase 415 trials
Phase 4 NCT07022496 Background Apr 2023 → Jul 2025 overdue migraine disorder Ain Shams University Recruiting No outcome recorded
Phase 4 NCT05108688 Comparator Nov 2021 → Dec 2023 headache disorder Ain Shams University Completed No outcome recorded
Phase 4 NCT04257851 Comparator Feb 2020 → May 2021 intracranial hypotension Damanhour Teaching Hospital Completed No outcome recorded
Phase 4 NCT02670161 Comparator May 2016 → Dec 2026 expected Parkinson disease, brain neoplasm, cognitive impairment with or without cerebellar ataxia, epilepsy +6 Endeavor Health Enrolling by invitation No outcome recorded
Phase 4 NCT01329562 Comparator May 2011 → Jun 2012 migraine disorder Cady, Roger, M.D. Completed No outcome recorded
Phase not applicable14 trials
NCT06617832 Comparator Nov 2024 → Sep 2028 expected migraine with aura, migraine without aura University of Aarhus Recruiting No outcome recorded
NCT06514040 Comparator Nov 2023 → Aug 2024 intracranial hypotension Fayoum University Hospital Completed No outcome recorded
NCT05211050 Comparator Mar 2022 → Nov 2023 migraine without aura Danish Headache Center Completed No outcome recorded
NCT03878784 Comparator Nov 2018 → Dec 2019 rosacea Danish Headache Center Completed No outcome recorded
NCT03881644 Comparator Jul 2018 → Dec 2019 migraine without aura Danish Headache Center Completed No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2016-06-27 Teva Branded Pharmaceutical Products R&D, Inc. Teva and Antares Pharma Announce Launch of Generic Imitrex® in the United States tevapharm.com
2015-09-01 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces U.S. Availability of ZECUITY® (sumatriptan iontophoretic transdermal system), First and Only Transdermal Patch System for the Acute Treatment of Migraine tevapharm.com
2009-02-11 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval and Launch of Generic Imitrex® Tablets tevapharm.com
2006-11-29 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Tentative Approval Of Sumatriptan Succinate Tablets tevapharm.com

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

“BACKGROUND: DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg” PMID 28251391 Mar 2017

“Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.” NCT01329562

“nortriptyline ,propranolol ,ergotamine , sumatriptan tablets” NCT01476930

“Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium” NCT01086358

“migraine (sumatriptan, rizatriptan, zolmitriptan)” NCT02670161

“TREXIMET® (Sumatriptan + Naproxen Sodium)” NCT00573170

“oral sumatriptan succinate” NCT01381796

SumatriptanNCT00724815

SumatriptanNCT02684409

SumatriptanNCT07022496

NCT00893594

NCT03422796

NCT00433732

NCT03156920

NCT01430442

NCT01986088

NCT00382993

NCT00792636

NCT05211050

NCT01986270

NCT00449787

NCT01632657

NCT00897104

NCT03076970

NCT01300546

NCT00650247

NCT00963937

NCT00847405

NCT04257851

NCT01507610

NCT01667679

NCT00510419

NCT01090050

NCT01016834

NCT01053507

NCT03185143

NCT00399243

NCT00846885

NCT02741310

NCT00701389

NCT02486276

NCT01248468

NCT02932488

NCT06514040

NCT04197349

NCT00723983

NCT00843024

NCT01814189

NCT07515456

NCT00546650

NCT00724815

NCT04355845

NCT00898677

NCT03338920

NCT00356603

NCT00442221

NCT00387881

NCT02054299

NCT01071317

NCT00240630

NCT00240617

NCT00894556

NCT05064488

NCT01462812

NCT02643719

NCT05108688

NCT00620425

NCT00434083

NCT00399633

NCT00329459

NCT00385008

NCT04948164

NCT00720018

NCT00989625

NCT00804973

NCT03310411

NCT00892203

NCT02485340

NCT00488514

NCT02856802

NCT00648466

NCT01854385

NCT00383162

NCT01579383

NCT01791400

NCT03542357

NCT04690270

NCT01807234

NCT05654298

NCT02954276

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 NCT02571049
1

NCT02569853

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

NCT03878784

NCT03881644

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

NCT00846885

NCT01450995

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 succinateNCT01381796

Sumatriptan Succinate Tablets 100 mg” NCT00648466

sumatriptan succinate 100 mg” NCT00920686

NCT00329355

NCT00893737

NCT03229798

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