Drugs / Zolmitriptan
Zolmitriptan
also known as
CVT-427 · Zomig · 311-C-90 · ADAM zolmitriptan · NSC-760383 · Rapimelt · ZNS · Zolmitriptan Nasal Spray · +3 more
Small molecule targets HTR1B, HTR1D via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT00442936 Comparator | Feb → Oct 2007 | migraine disorder | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-06-20 | Upsher-Smith Laboratories | Regulatory Announcement on Completion of Transfer of Manufacturing and Marketing Approval of Zomig Tablets 2.5 mg and Zomig RM Tablets 2.5 mg upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today announced that it has completed the transfer of manufacturing and marketing approval of Zomig® Tablets 2.5 mg and Zomig® RM Tablets 5 mg* |
| 2015-06-16 | Impax Laboratories, LLC | Regulatory FDA Approves ZOMIG® (zolmitriptan) Nasal Spray for Migraine in Pediatric Patients (Ages 12-17) amneal.com ↗
Impax Specialty Pharma, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today that the U.S. Food and Drug Administration ( FDA ) has approved ZOMIG Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. |
All press releases naming this drug 8 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited 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 202121“Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan” NCT01086358 ↗ “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: Zolmitriptan” NCT03145467 ↗ |
| 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“Zomig” NCT03145467 ↗ |
| Known as | Zomig Nasal Spray | “Zomig Nasal Spray” NCT03978403 ↗ |
| 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 ↗ |