Drugs / rizatriptan
rizatriptan
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | RIZAPORT | migraine disorder | 2017-11-01 | “today announced that they have resubmitted the 505(b)(2) New Drug Application (NDA) for RIZAPORT® 10mg to the U.S. Food and Drug Administration (FDA).” redhillbio.com ↗ “Marketing applications for RIZAPORT™ have been filed both in the U.S. (NDA filed in March 2013) and in Europe (MAA filed in October 2014).” redhillbio.com ↗ “RedHill and IntelGenx submitted a New Drug Application (NDA) to the FDA in 2013 seeking marketing approval of RIZAPORT(TM) in the U.S.” redhillbio.com ↗ “A New Drug Application for RIZAPORT(TM) was also filed with the U.S.FDA in 2013 and a CRL was received in 2014.” redhillbio.com ↗ “A New Drug Application for RIZAPORT® was also filed with the U.S.FDA in 2013 and a CRL was received in 2014.” redhillbio.com ↗ |
| Rejected (CRL) | US (FDA) | RIZAPORT | migraine disorder | — | “Following a first NDA submission to the FDA in March 2013, RedHill and IntelGenx received a Complete Response Letter (CRL) from the FDA.” redhillbio.com ↗ “In February 2014, the companies received a complete response letter (CRL) from the FDA which raised questions primarily related to CMC.” redhillbio.com ↗ “Following a complete response letter (CRL) received from the FDA in February 2014, which raised questions primarily related to CMC” redhillbio.com ↗ “In 2014, the companies received a complete response letter (CRL) from the FDA which raised questions primarily related to CMC.” redhillbio.com ↗ |
| Filed | EU (EMA) | RIZAPORT | migraine disorder | — | “Marketing applications for RIZAPORT™ have been filed both in the U.S. (NDA filed in March 2013) and in Europe (MAA filed in October 2014).” redhillbio.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00604812 | Dec 2007 → Sep 2010 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT02447991 | Dec 2014 → Jul 2020 | migraine disorder | Robert W. Baloh | Completed | Missed primary |
| Phase 321 trials · 6 met primary | ||||||
| Phase 3 | NCT04384367 | Dec 2022 → Oct 2024 | migraine disorder | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05550207 | Aug 2022 → Nov 2024 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04163185 | Oct 2019 → Mar 2020 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04068051 | Jul 2019 → Sep 2020 | migraine disorder | Axsome Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01004263 | Dec 2009 → Apr 2011 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01001234 | Nov 2009 → Apr 2011 | migraine disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00894556 | Jun 2009 → Jan 2010 | migraine disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00812006 | Mar → Oct 2009 | migraine disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00516737 | Oct 2007 → Apr 2008 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00471952 | Apr 2007 → Feb 2008 | migraine with aura, migraine without aura | Diamond Headache Clinic | Completed | No outcome recorded |
| Phase 3 | NCT00300924 | Mar 2006 → Jan 2007 | migraine disorder | Diamond Headache Clinic | Completed | No outcome recorded |
| Phase 3 | NCT00250458 | Mar → Oct 2006 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00111722 | May 2005 → Feb 2006 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00111709 | May 2005 → Feb 2006 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00095004 | Oct 2004 → Apr 2005 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092963 | Aug 2004 → Jan 2005 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00898677 | Sep 1995 → May 1996 | migraine disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00897104 | Aug 1995 → May 1996 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00899379 | Apr 1995 → Jan 1996 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00897949 | Mar 1995 → Jan 1996 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01286207 | Mar 1995 → May 1997 | migraine disorder | Organon and Co | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01057160 | May 2008 → Jun 2010 | migraine disorder | University of Duisburg-Essen | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT00360282 | Aug 2006 → Jan 2009 | migraine disorder | University of Pittsburgh | Completed | Met primary |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT00246337 Comparator | Nov 2005 → May 2006 | migraine disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03896009 Comparator | Mar → Dec 2019 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT00443209 Comparator | Feb 2007 → Jan 2009 | migraine disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| 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 |
| Phase 4 | NCT00753311 Comparator | Jul 2009 → Nov 2010 | migraine disorder | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 4 | NCT00397254 Comparator | Dec 2006 → Jan 2008 | migraine disorder | Clinvest | Completed | No outcome recorded |
| Phase 4 | NCT00910689 Comparator | Jul 2001 → Nov 2005 | migraine disorder | Ohio University | Completed | No outcome recorded |
| — | NCT01306266 Comparator | Feb → Aug 2011 | — | Henry M. Jackson Foundation for the Advancement of Military Medicine | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces SYMBRAVO® (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors gcs-web.com ↗
SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint) |
| 2025-01-30 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults gcs-web.com ↗ |
| 2020-09-24 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial. |
| 2019-09-05 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Positive AXS-07 Phase 1 Trial Results at the 19th Congress of the International Headache Society gcs-web.com ↗
Results of the Phase 1 trial demonstrated that AXS-07 is rapidly absorbed after oral administration, with the MoSEIC meloxicam component also displaying an extended plasma half-life, suggesting the potential for enhanced and sustained efficacy. |
| 2017-11-01 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines redhillbio.com ↗ |
| 2017-04-13 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Announce Marketing Approval of RIZAPORT® for Migraines in Luxembourg redhillbio.com ↗
today announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT® (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines. |
| 2015-11-09 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Announce First European Marketing Approval of RIZAPORT(TM) (RHB-103) for Migraines redhillbio.com ↗
The German Federal Institute for Drugs and Medical Devices (BfArM) has granted national marketing approval for RIZAPORT(TM) (RHB-103) for the treatment of acute migraines under the European Decentralized Procedure (DCP) |
| 2015-09-10 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Announce RIZAPORT(TM) (RHB-103) Marketing Authorization Application is Approvable Under the European Decentralized Procedure redhillbio.com ↗
The German Federal Institute for Drugs and Medical Devices (BfArM) has confirmed the positive outcome of the European Decentralized Procedure and informed RedHill and IntelGenx that the European Marketing Authorization Application (MAA) for RIZAPORT™(RHB-103) is approvable |
| 2015-09-10 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces RIZAPORT (RHB-103) Marketing Authorization Application is Approvable Under the European Decentralized Procedure redhillbio.com ↗
The German Federal Institute for Drugs and Medical Devices (BfArM) has confirmed the positive outcome of the European Decentralized Procedure and informed RedHill and IntelGenx that the European Marketing Authorization Application (MAA) for RIZAPORT™ (RHB-103) is approvable |
| 2014-12-01 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Announce Acceptance for Review of European Marketing Application for RIZAPORT™ for Migraines redhillbio.com ↗
The German Federal Institute for Drugs and Medical Devices (BfArM) has validated the European Marketing Authorization Application submitted for RIZAPORT™ (RHB-103) and initiated its formal review of the application on November 25, 2014 |
| 2014-10-01 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Submit European Marketing Authorization Application for Migraine Drug RIZAPORT(R) (formerly RHB-103) redhillbio.com ↗
The MAA was submitted under the European Mutual Recognition Procedure ("MRP") with Germany as the reference member state. |
| 2014-10-01 | RedHill Biopharma Limited | Regulatory IntelGenx and RedHill Biopharma Submit European Marketing Authorization Application for Migraine Drug RIZAPORT(R) redhillbio.com ↗
The MAA was submitted under the European Mutual Recognition Procedure (MRP) with Germany as the reference member state. |
| 2014-06-18 | RedHill Biopharma Limited | Regulatory RedHill Announces FDA Acceptance for Review of RHB-103 (Migraine) NDA and PDUFA Date redhillbio.com ↗
The acceptance of the NDA for review reflects FDA's determination that the application is sufficiently complete to permit a substantive review of RedHill’s RHB-103 marketing application. |
| 2014-05-21 | RedHill Biopharma Limited | Results RedHill Biopharma and IntelGenx Report Positive RHB-103 Bioavailability Study Results redhillbio.com ↗
The study, which included 26 healthy volunteers, established the bioequivalence of RHB-103 and the European reference drug, Maxalt® lingua. |
| 2014-05-21 | RedHill Biopharma Limited | Results RedHill Biopharma and IntelGenx Report Positive RHB-103 Bioavailability Study Results in Support of Planned European Marketing Application in Q3/2014 redhillbio.com ↗
The study, which included 26 healthy volunteers, established the bioequivalence of RHB-103 and the European reference drug, Maxalt® lingua. |
| 2014-05-21 | RedHill Biopharma Limited | Results IntelGenx and RedHill Biopharma Report Positive Bioavailability Study Results in Support of Planned European Marketing Application in Q3/2014 for Anti-Migraine VersaFilm(TM) Product redhillbio.com ↗
The study, which included 26 healthy volunteers, established the bioequivalence of the anti-migraine VersaFilm™ product and the European reference drug, Maxalt® lingua. |
| 2014-04-24 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Provide an Update on FDA's Ongoing Review of the NDA for RHB-103 Oral Migraine Film redhillbio.com ↗ |
| 2014-04-24 | RedHill Biopharma Limited | Regulatory IntelGenx and RedHill Biopharma Provide an Update on FDA's Ongoing Review of the NDA for Migraine VersaFilm(TM) Product redhillbio.com ↗
In response, the FDA has requested from the Companies additional CMC data, which the Companies believe they can supply within several weeks based on available information. |
| 2014-03-03 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Submit Response to FDA CRL for RHB-103 Migraine Oral-Film redhillbio.com ↗
they submitted a response to the Complete Response Letter ("CRL") of the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") for RHB-103 |
| 2014-02-04 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Receive Complete Response Letter from FDA for RHB-103 Oral Film for Acute Migraines redhillbio.com ↗
today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for RHB-103 for the treatment of acute migraines. |
| 2014-02-04 | RedHill Biopharma Limited | Regulatory IntelGenx and RedHill Biopharma Receive Complete Response Letter From FDA for VersaFilm(TM) Oral Film Product for Acute Migraines redhillbio.com ↗
today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for their VersaFilm™ Oral Film Product for the treatment of acute migraines. |
| 2013-06-18 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Acceptance for Review of RHB-103 NDA for Acute Migraine and PDUFA Goal Date of February 3, 2014 redhillbio.com ↗ |
| 2013-03-27 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Submits New Drug Application to U.S. FDA for RHB-103 Anti-Migraine Oral Thin Film redhillbio.com ↗ |
| 2008-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Generic Maxalt® Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval |
All press releases naming this drug 26 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rizatriptan | “The choice of triptans (rizatriptan®, sumatriptan®), the route(s) of triptan administration (oral, nasal spray, subcutaneous injection), and the addition of a NSAID, or...” NCT00910689 ↗33“The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine.” NCT00471952 ↗ “Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan” NCT01086358 ↗ “AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.” NCT04068051 ↗ “migraine (sumatriptan, rizatriptan, zolmitriptan)” NCT02670161 ↗ |
| Known as | MAXALT | “Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence.” PMID 9595867 ↗ Apr 1998 |
| Known as | MK0462 | “Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate” NCT00250458 ↗5“MK0462, rizatriptan benzoate / Duration of Treatment -1 day” NCT00111709 ↗ “MK0462, rizatriptan benzoate / Duration of Treatment -1day” NCT00111722 ↗ “MK0462, rizatriptan benzoate / Duration of Treatment: 1day” NCT00092963 ↗ “MK0462, rizatriptan benzoate / Duration of Treatment: 1day” NCT00095004 ↗ “rizatriptan benzoate (MK0462)” NCT00897949 ↗ |
| Known as | rizatriptan benzoate | “MK0462, rizatriptan benzoate / Duration of Treatment -1 day” NCT00111709 ↗5“MK0462, rizatriptan benzoate / Duration of Treatment: 1day” NCT00095004 ↗ “MK0462, rizatriptan benzoate / Duration of Treatment: 1day” NCT00092963 ↗ “MK0462, rizatriptan benzoate / Duration of Treatment -1day” NCT00111722 ↗ “rizatriptan benzoate (MK0462)” NCT00897104 ↗ “rizatriptan benzoate (MK0462)” NCT00897949 ↗ |
| Action | Activate | “Rizatriptan is a novel 5-HT1B/1D agonist” PMID 9595867 ↗ Apr 1998 |
| Route | Oral | “Rizatriptan 10 mg; one orally-administered dose” NCT00246337 ↗ |