Drugs / almotriptan

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 No outcome recorded
Phase 46 trials
Phase 4 NCT05214001 Jun 2022 → Apr 2024 migraine with aura, migraine without aura Messoud Ashina, MD Terminated No outcome recorded
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 No outcome recorded
Phase 4 NCT00212823 Jun 2004 → Feb 2005 migraine disorder Ortho-McNeil Neurologics, Inc. Completed No outcome recorded
Phase 4 NCT00208065 May 2004 → Nov 2005 migraine disorder, sinusitis Clinvest Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT01086358 Comparator Sep 2009 → Aug 2016 The Cleveland Clinic Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2015-07-08 Teva Branded Pharmaceutical Products R&D, Inc. Teva First to Receive Approval and Launch Generic Axert® Tablets in the United States tevapharm.com

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as almotriptan “Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan” NCT01086358
6

NCT00208065

NCT00432549

NCT05214001

NCT00210496

NCT00210483

NCT00212823

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

NCT00257010

NCT00210509

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 1d (5-HT1d) receptor agonist” CHEMBL1505
2

“Serotonin 1b (5-HT1b) receptor agonist” CHEMBL1505

“Serotonin 1f (5-HT1f) 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