Imitrex

(Sumatriptan)

ApprovedBiologic

Sumatriptan is used to treat migraine headaches by narrowing blood vessels around the brain and reducing substances in the body that can cause headaches, nausea, sensitivity to light and sound, and other migraine symptoms.[2] Imitrex is currently approved and in use across 7 indications[4].[1]

Imitrex is one of 152 biologic programs targeting Migraine Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

151

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Migraine DisorderActive, not recruiting

MigraineApproved

ObesityApproved

Cesarean SectionActive, not recruiting

Migraine With AuraActive, not recruiting

Migraine DisorderApproved

Active, not recruiting

MigraineApproved

Approved

ObesityApproved

Approved

Cesarean SectionPreclinical

Active, not recruiting

Migraine With AuraPreclinical

Active, not recruiting

Competition

Competitive Landscape

392 competitors in Obesity

#DrugCompanyPhaseTrials

Imitrex

GGlaxo Dba Glaxosmithkline

Approved

48 2

Actemra

Roche

Preclinical

2 3

Amidate

Pfizer

Preclinical

—4

Calciferol

Alnylam Pharmaceuticals

Adenocard

Activella

Colcrys

Alnylam Pharmaceuticals

Preclinical

—8

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 9

Cetrotide

EMD Serono

Preclinical

2 10

Oxycontin

PProtega

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Recruiting

Infants

NCT03511118

Clinical

Trials by Indication[1]

Migraine14 trials

Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine

Completed·OOptinose US Inc.·Phase 3·NCT01462812·223 enrolled

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Completed· Pfizer logo

Pfizer·Phase 2·NCT01430442·1,026 enrolled

Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea

Completed·AAllodynic Therapeutics, Inc·Phase 2/3·NCT03185143·36 enrolled

Show 11 more trials

Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents

Completed· GSK logo

GSK·Phase 3·NCT00963937·178 enrolled

Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT01986088·1,008 enrolled

Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents

Terminated·CCurrax Pharmaceuticals·Phase 3·NCT03338920·159 enrolled

Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I

Recruiting·HHospital Universitari Vall d'Hebron Research Institute··NCT06503848·108 enrolled

Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine

Completed·DDanish Headache Center·N/A·NCT05211050·24 enrolled

Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

Completed· Novartis logo

Novartis·Phase 4·NCT01248468·752 enrolled

Trial of Comprehensive Migraine Intervention

Completed·MMontefiore Medical Center·Phase 4·NCT01071317·50 enrolled

Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine

Completed·JJohns Hopkins University·Phase 4·NCT01807234·72 enrolled

Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00701389·24 enrolled

Efficacy and Safety of BGG492 in the Treatment of Migraine

Completed· Novartis logo

Novartis·Phase 2·NCT00892203·75 enrolled

Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine

Completed·ZZogenix, Inc.·Phase 4·NCT01016834·246 enrolled

Headache11 trials

The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

Completed·DDanish Headache Center·N/A·NCT02485340·30 enrolled

Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

Completed·DDanish Headache Center·N/A·NCT03156920·30 enrolled

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

Completed·PPOZEN·Phase 3·NCT00434083·1,200 enrolled

Show 8 more trials

Sumatriptan as Treatment for Post-traumatic Headache

Completed·UUniversity of Washington·Phase 2·NCT01854385·40 enrolled

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period

Completed· GSK logo

GSK·Phase 4·NCT00792636·407 enrolled

Comparing Naproxen to Sumatriptan for Emergency Headache Patients

Completed·MMontefiore Medical Center·Phase 4·NCT00449787·401 enrolled

The Effect of Sumatriptan and Placebo on CGRP Induced Headache

Completed·DDanish Headache Center·N/A·NCT03542357·30 enrolled

The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Completed·DDanish Headache Center·N/A·NCT02486276·30 enrolled

Study in Participants With Acute Migraines Headaches

Terminated· Eli Lilly logo

Eli Lilly·Phase 2·NCT00804973·120 enrolled

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches

Completed·PPOZEN·Phase 3·NCT00433732·1,400 enrolled

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Completed·—·Phase 4·NCT05108688·210 enrolled

Tics2 trials

Safety Tolerability and Pharmacokinetics of ALD403

Completed·AAlder Biopharmaceuticals, Inc.·Phase 1·NCT01579383·104 enrolled

Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT04197349·96 enrolled

Fed2 trials

Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions

Completed·—·Phase 1·NCT01269281·50 enrolled

Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00872274·32 enrolled

Oral2 trials

Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT01986270·1,141 enrolled

Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03076970·42 enrolled

16 more indications

Postoperative Quality of Recovery1 trial

Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy

Completed·UUniversity Health Network, Toronto·N/A·NCT01632657·40 enrolled

ART1 trial

A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03310411·40 enrolled

Drug1 trial

Drug Use Investigation for IMIGRAN Tablet

Completed· GSK logo

GSK··NCT01376141·3,571 enrolled

Pregnancy1 trial

Sumatriptan and Naratriptan Pregnancy Registry

Completed· GSK logo

GSK··NCT01059604·868 enrolled

MPA1 trial

Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects

Completed·OOptinose US Inc.·Phase 1·NCT01507610·20 enrolled

ALD1 trial

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT05654298·20 enrolled

Cesarean Section1 trial

Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section

Completed·FFayoum University Hospital·N/A·NCT06514040·48 enrolled

Efficacy and Safety1 trial

An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)

Completed·UUpsher-Smith Laboratories·Phase 2·NCT02856802·107 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00872924·32 enrolled

Interaction1 trial

Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05064488·40 enrolled

Single Dose1 trial

A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.

Completed· Pfizer logo

Pfizer·Phase 1·NCT04355845·10 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Blood Pressure1 trial

Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

Completed· Amgen logo

Amgen·Phase 1·NCT02741310·34 enrolled

Peptides1 trial

Neuropeptides in the Humane Intra- og Extracerebral Circulation.

Completed·DDanish Headache Center·N/A·NCT00399633·16 enrolled

Local1 trial

A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs

Completed·ZZogenix, Inc.·Phase 1·NCT00620425·18 enrolled

Unspecified2 trials

Sumatriptan and Glucose

Unknown status·—·Phase 1·NCT04690270·12 enrolled

Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation

Terminated·GGitte Moos Knudsen·Phase 1·NCT02932488·17 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 28, 1992

IMITREX

NDA NDA020080

Jun 1, 1995

IMITREX

NDA NDA020132

Aug 26, 1997

IMITREX

NDA NDA020626

Jun 29, 2010

ALSUMA

NDA NDA022377

Jan 17, 2013

ZECUITY

NDA NDA202278

Nov 26, 2013

SUMAVEL DOSEPRO

NDA NDA022239

Jan 27, 2016

ONZETRA XSAIL

NDA NDA206099

Jan 28, 2016

ZEMBRACE SYMTOUCH

NDA NDA208223

Jan 25, 2019

TOSYMRA

NDA NDA210884

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Sumatriptan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Imitrex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sumatriptan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sumatriptan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210884). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Imitrex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 1b (5-Ht1b) Receptor Agonist; Serotonin 1d (5-Ht1d) Receptor Agonist[3]
Modality: Biologic[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Patent Landscape[6]

Patent Cliff

Jul 31, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11571531Feb 23, 2026

9283280May 9, 2026

8440631May 9, 2026

8268791May 9, 2026

7901385Jul 31, 2026

31 more patents

7776007Nov 22, 2026

10124132Mar 6, 2027

8470853Apr 12, 2027

8597272Apr 12, 2027

9427578Apr 12, 2027

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7973058Apr 12, 2027

7811254Aug 26, 2027

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8875704Apr 7, 2028

10722667Dec 30, 2028

8366600Apr 21, 2029

10076615Jul 30, 2029

8550073Oct 22, 2029

10603305Jun 16, 2030

9974770Jun 16, 2030

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9610280Jun 16, 2030

12090139Jun 16, 2030

8899229Aug 18, 2030

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8983594Nov 19, 2030

8978647Dec 6, 2030

9211282Jul 19, 2031

9327114Oct 8, 2032

10478574Nov 4, 2033

10076614Oct 20, 2034

12097183Jan 29, 2036

10537554Jan 29, 2036

11364224Jan 29, 2036

Imitrex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Trials by Indication[1]

Migraine14 trials

Headache11 trials

Tics2 trials

Fed2 trials

Oral2 trials

Postoperative Quality of Recovery1 trial

ART1 trial

Drug1 trial

Pregnancy1 trial

MPA1 trial

ALD1 trial

Cesarean Section1 trial

Efficacy and Safety1 trial

Fasting Conditions1 trial

Interaction1 trial

Single Dose1 trial

Infants1 trial

Blood Pressure1 trial

Peptides1 trial

Local1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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