Drugs / almotriptan
almotriptan
also known as
almotriptan malate · AXERT · Almogran · Almotriptan d,l-hydrogenmalate · Almotriptan maleate · LAS 31416 · LAS 31416 D,L-MALATE ACID · NSC-760092 · +1 more
Small molecule targets HTR1B, HTR1D, HTR1F via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | AXERT | — | 2009-04-30 | fda.gov ↗ |
| Approved | US (FDA) | AXERT | — | 2001-05-07 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT00257010 | Dec 2005 → Dec 2007 | migraine disorder | Janssen-Ortho LLC | Completed | No outcome recorded |
| Phase 3 | NCT00210483 | Jul 2003 → Jul 2005 | migraine disorder | Janssen-Ortho LLC | Completed | Mixed |
| Phase 46 trials · 2 met primary | ||||||
| Phase 4 | NCT05214001 | Jun 2022 → Apr 2024 | migraine with aura, migraine without aura | Messoud Ashina, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00432549 | Jan → Feb 2007 | — | The New England Center for Headache, P.C. | Unknown | No outcome recorded |
| Phase 4 | NCT00210496 | Jun 2005 → Jun 2007 | migraine with aura, migraine without aura | Janssen-Ortho LLC | Completed | No outcome recorded |
| Phase 4 | NCT00210509 | Nov 2004 → Jun 2005 | migraine disorder | Janssen-Ortho LLC | Completed | Met primary |
| Phase 4 | NCT00212823 | Jun 2004 → Feb 2005 | migraine disorder | Ortho-McNeil Neurologics, Inc. | Completed | Met primary |
| Phase 4 | NCT00208065 | May 2004 → Nov 2005 | migraine disorder, sinusitis | Clinvest | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT01086358 Comparator | Sep 2009 → Aug 2016 | — | The Cleveland Clinic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2015-07-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva First to Receive Approval and Launch Generic Axert® Tablets in the United States tevapharm.com ↗
Teva is the first applicant to receive approval and will have a period of market exclusivity until the pediatric exclusivity associated with the only patent for Axert® expires on November 7, 2015. |
| 2003-12-01 | Almirall, S.A. | Regulatory Almotriptan receives approval to be sold in Canada Almirall almirall.com ↗
Almotriptan, a medicine which was entirely researched and developed by Almirall, has received the approval of the Health Products and Food Brands , the Canadian health agency, for the treatment of migraines. |
| 2003-10-07 | Almirall, S.A. | Regulatory Canada: another key approval for almotriptan almirall.com ↗
On September 30th, 2003, Almirall has obtained the regulatory approval of its molecule almotriptan from the Health Authorities in Canada for the treatment of migraine. |
| 2001-05-10 | Almirall, S.A. | Regulatory Almotriptan (Almogran) is licensed by the FDA for marketing in the United States. almirall.com ↗
Almirall Prodesfarma, the leading Spanish multinational pharmaceutical company, announces today that the Food & Drug Administration (FDA) has for the first time licensed a chemical researched and developed in Spain, Almotriptan (Almogran), for marketing in the United States. |
All press releases naming this drug 8 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Almotriptan | “Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan” NCT01086358 ↗ |
| Known as | Almogran | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Known as | Almotriptan d,l-hydrogenmalate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Known as | almotriptan malate | “A Randomized, Double-blind, Placebo-controlled Study of Oral Almotriptan Malate (AXERT®) 6.25 mg, 12.5 mg, and 25 mg in the Acute Treatment of Migraine in Adolescents” NCT00210483 ↗3“The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain” NCT00212823 ↗ |
| Known as | Almotriptan maleate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Known as | AXERT | “A Randomized, Double-blind, Placebo-controlled Study of Oral Almotriptan Malate (AXERT®) 6.25 mg, 12.5 mg, and 25 mg in the Acute Treatment of Migraine in Adolescents” NCT00210483 ↗3“Efficacy of AXERT (Almotriptan Malate) in the Acute Treatment of Migraine: A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX (Topiramate)” NCT00210496 ↗ “Almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache” NCT00210509 ↗ “The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain” NCT00212823 ↗ |
| Known as | LAS 31416 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Known as | LAS 31416 D,L-MALATE ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Known as | NSC-760092 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Known as | PNU-180638E | ChEMBL registry synonym — accepted as the source's own label CHEMBL1505 ↗ |
| Action | Activate | “Serotonin 1f (5-HT1f) receptor agonist” CHEMBL1505 ↗2“Serotonin 1d (5-HT1d) receptor agonist” CHEMBL1505 ↗ “Serotonin 1b (5-HT1b) receptor agonist” CHEMBL1505 ↗ |
| Modality | Small molecule | — CHEMBL1505 ↗ |
| Route | Oral | “receive one oral dose of almotriptan malate (AXERT®) 6.25, 12.5, or 25 milligrams or placebo” NCT00210483 ↗ |
| Target | HTR1B | “Serotonin 1b (5-HT1b) receptor agonist” CHEMBL1505 ↗ |
| Target | HTR1D | “Serotonin 1d (5-HT1d) receptor agonist” CHEMBL1505 ↗ |
| Target | HTR1F | “Serotonin 1f (5-HT1f) receptor agonist” CHEMBL1505 ↗ |