Drugs / Zolmitriptan

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (4) US (FDA) ZOMIG 2004-11-16 – 2015-06-12 fda.gov
Approved US (FDA) ZOMIG 1997-11-25 fda.gov

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05019430 Oct 2021 → Jan 2025 substance-related disorder William Stoops Completed No outcome recorded
Phase 17 trials
Phase 1 NCT06074016 Jul → Sep 2023 Parc de Salut Mar Completed No outcome recorded
Phase 1 NCT04969497 Jun → Sep 2021 migraine disorder Zosano Pharma Corporation Completed No outcome recorded
Phase 1 NCT03978403 May → Jun 2019 migraine disorder Zosano Pharma Corporation Completed No outcome recorded
Phase 1 NCT03708744 Nov 2018 migraine disorder Zosano Pharma Corporation Completed No outcome recorded
Phase 1 NCT02905227 Sep → Dec 2016 migraine disorder Acorda Therapeutics Completed No outcome recorded
Phase 1 NCT02609945 Nov → Dec 2015 migraine disorder Acorda Therapeutics Completed No outcome recorded
Phase 1 NCT01085123 May → Oct 2010 migraine disorder AstraZeneca Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT04066023 Oct 2019 → Apr 2021 cluster headache syndrome Zosano Pharma Corporation Completed No outcome recorded
Phase 2/3 NCT02745392 Jun 2016 → Jan 2017 migraine disorder Zosano Pharma Corporation Completed No outcome recorded
Phase 34 trials
Phase 3 NCT03275922 Nov 2017 → Jul 2020 migraine disorder Impax Laboratories, LLC Completed No outcome recorded
Phase 3 NCT03282227 Nov 2017 → May 2019 migraine disorder Zosano Pharma Corporation Completed No outcome recorded
Phase 3 NCT00617695 Sep 2003 → Oct 2004 migraine disorder Impax Laboratories, LLC Completed No outcome recorded
Phase 3 NCT00617747 Sep 2002 → Jun 2003 migraine disorder AstraZeneca Completed No outcome recorded
Phase 44 trials
Phase 4 NCT03377257 Jan → Dec 2018 cluster headache syndrome Xijing Hospital Unknown No outcome recorded
Phase 4 NCT03145467 Jan → Dec 2016 migraine disorder Pamukkale University Completed No outcome recorded
Phase 4 NCT01211145 Sep 2010 → Oct 2013 migraine disorder AstraZeneca Completed No outcome recorded
Phase 4 NCT00637286 Jul 2004 → May 2005 migraine disorder AstraZeneca Completed No outcome recorded
Phase not applicable1 trial
NCT01276977 Apr 2008 → Dec 2010 migraine disorder California Medical Clinic for Headache Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT00442936 Comparator Feb → Oct 2007 migraine disorder Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 42 trials
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 NCT01086358 Comparator Sep 2009 → Aug 2016 The Cleveland Clinic Completed No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

FieldValueCited text
Known as zolmitriptan “M207 is an investigational microneedle-based system for intracutaneous delivery of zolmitriptan for the treatment of migraine attacks.” PMID 34001002 May 2021
21

“Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptanNCT01086358

“The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.” NCT04066023

“Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers” NCT01085123

“migraine (sumatriptan, rizatriptan, zolmitriptan)” NCT02670161

Zolmitriptan Nasal Spray” NCT03275922

“Drug: ZolmitriptanNCT03145467

NCT03708744

NCT02609945

NCT02745392

NCT00442936

NCT03377257

NCT06074016

NCT05019430

NCT01211145

NCT04969497

NCT00617695

NCT03978403

NCT01276977

NCT02905227

NCT00637286

NCT00617747

Known as 311-C-90 ChEMBL registry synonym — accepted as the source's own label CHEMBL1185
Known as ADAM zolmitriptan “Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine.” PMID 29022755 Oct 2017
Known as CVT-427 “Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.” NCT02905227
1

“This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder)” NCT02609945

Known as NSC-760383 ChEMBL registry synonym — accepted as the source's own label CHEMBL1185
Known as Rapimelt “ZOMIG® Rapimelt (Zolmitriptan)” NCT01085123
Known as ZNS “To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.” NCT03275922
Known as Zolmitriptan Nasal Spray “To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.” NCT03275922
Known as ZOMIG “Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose” NCT03978403
1

ZomigNCT03145467

Known as Zomig Nasal Spray Zomig Nasal SprayNCT03978403
Known as Zomig-zmt ChEMBL registry synonym — accepted as the source's own label CHEMBL1185
Known as ZP-Zolmitriptan ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system” NCT02745392
Action Activate “zolmitriptan, a commercially available selective 5-HT1b agonist migraine medication” NCT05019430
2

“Serotonin 1b (5-HT1b) receptor agonist” CHEMBL1185

“Serotonin 1d (5-HT1d) receptor agonist” CHEMBL1185

Modality Small molecule CHEMBL1185
Route Oral “Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache.” NCT00442936
Target HTR1B “Serotonin 1b (5-HT1b) receptor agonist” CHEMBL1185
Target HTR1D “Serotonin 1d (5-HT1d) receptor agonist” CHEMBL1185