Topiramate
Small molecule targets GRIK5, GRINA, PRKACA, PRKCI, SNAP23, TRAK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | TOPAMAX SPRINKLE | — | 1999-07-23 – 2022-01-13 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | QUDEXY XR | — | 2015-03-30 – 2017-03-29 | fda.gov ↗ |
| Label expansion | US (FDA) | TROKENDI XR | — | 2016-08-18 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Qsiva | — | 2013-05-14 | europa.eu ↗ |
| Approved | US (FDA) | TOPAMAX | — | 1996-12-24 | fda.gov ↗ |
Trials 217 · started per year
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2025-06-18 | AbbVie | Results AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention abbvie.com ↗
The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. |
| 2025-03-10 | VIVUS LLC | Regulatory VIVUS Launches QSYMIA in the United Arab Emirates vivus.com ↗
announced the market approval of QSYMIA® (phentermine and topiramate extended-release capsules) CIV in the United Arab Emirates (UAE) for treatment of overweight and obesity in adults and pediatric patients, age 12 and older. |
| 2024-10-28 | VIVUS LLC | Regulatory VIVUS Shares Significant Regulatory Update on QSYMIA vivus.com ↗
VIVUS announced today that the U.S. Food and Drug Administration has removed the requirement for a cardiovascular outcome trial for its weight - management medication QSYMIA (phentermine and topiramate extended release capsules) CIV. |
| 2024-10-23 | VIVUS LLC | Regulatory VIVUS Announces Labeling Update vivus.com ↗
VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced the United States Food and Drug Administration (FDA) approved a labeling update for QSYMIA® (phentermine and topiramate extended-release capsules CIV). |
| 2024-07-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Topiramate Capsules USP, 15 mg and 25 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Capsules USP, 15 mg and 25 mg. |
| 2023-11-28 | VIVUS LLC | Results New Clinical Data Demonstrate that QSYMIA, the Leading Once-Daily Oral Weight Management Medication, Reduces Blood Pressure vivus.com ↗
VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced positive topline data from a post-marketing study to evaluate the effect of QSYMIA® (phentermine and topiramate extended-release capsules CIV) on 24-hour ambulatory blood pressure (ABPM) (#NCT05215418). |
| 2023-05-17 | VIVUS LLC | Results VIVUS QSIVA in Combination with a Digital Lifestyle Intervention Leads to Significant Weight Loss and Decreased Cardiovascular Risk in Patients with Obesity vivus.com ↗
VIVUS BV, the European affiliate of VIVUS LLC (“VIVUS”), a biopharmaceutical company, today announced the results of a clinical study (NCT04408586) demonstrating that QSIVA (phentermine and topiramate modified-release) hard capsules in combination with a DLI resulted in significantly greater weight loss and cardiovascular risk reduction in patients with obesity compared with the DLI alone. |
| 2022-07-20 | VIVUS LLC | Regulatory FDA Approves QSYMIA for the Treatment of Obesity in Adolescents Ages 12 to 17 vivus.com ↗
FDA Approves QSYMIA® for the Treatment of Obesity in Adolescents Ages 12-17 |
| 2021-11-08 | Novartis Pharmaceuticals | Results Novartis announces new publication in Cephalalgia of data showcasing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention novartis.com ↗ |
| 2021-11-08 | Amgen | Results First And Only Randomized, Double-blind, Head-to-head Study Comparing Aimovig® (erenumab-aooe), An Anti-CGRP Pathway Therapy, To Topiramate Published In Cephalalgia amgen.com ↗
In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% versus 38.9%). |
| 2020-11-02 | Novartis Pharmaceuticals | Results Novartis announces positive results from a Phase IV study showing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention novartis.com ↗
The results of HER-MES showed that Aimovig had a superior tolerability and efficacy profile than topiramate, with less discontinuation over the course of the 24-week treatment phase. |
| 2019-12-18 | VIVUS LLC | Results VIVUS Announces New Data Supporting the Safety and Efficacy of Qsymia in Adolescents with Obesity vivus.com ↗
Data published in Diabetes, Obesity and Metabolism demonstrate that Qsymia provides statistically significant weight loss compared with placebo over an 8 week period, provide basis for ongoing 56 week phase 4 study in obese adolescents |
| 2019-11-20 | VIVUS LLC | Results New Clinical Data Demonstrate VIVUS Qsymia is Effective at Reducing Binge Eating in Patients with Binge Eating Disorder or Bulimia Nervosa vivus.com ↗
New Clinical Data Demonstrate VIVUS’ Qsymia® is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder or Bulimia Nervosa |
| 2019-10-07 | VIVUS LLC | Regulatory VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe vivus.com ↗ |
| 2019-08-20 | VIVUS LLC | Results New Pilot Clinical Study Results Demonstrate that Addition of VIVUS Qsymia to Gastric Sleeve Surgery Significantly Improves Weight Loss Compared with Surgery Alone vivus.com ↗
Study results show that patients taking it lost significantly more weight before surgery and had improved outcomes with respect to weight loss and BMI than those not on AOM. |
| 2019-08-05 | VIVUS LLC | Regulatory VIVUS Announces Approval of Qsymia in the Republic of Korea vivus.com ↗
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical company, announced today that its Korean marketing partner, Alvogen, has obtained marketing approval for Qsymia (phentermine and topiramate extended-release) from the South Korea Ministry of Food and Drug Safety (MFDS). |
| 2019-01-14 | VIVUS LLC | Results Data Supporting the Cardiovascular Safety of VIVUS Qsymia Published in The Journal of Clinical Endocrinology & Metabolism vivus.com ↗
The new findings indicate that the combined risk of major adverse cardiovascular events (MACE) was not elevated in patients currently taking Qsymia, or concurrently taking both phentermine and topiramate, compared with former users of these medications. |
| 2018-08-27 | VIVUS LLC | Results VIVUS Reports Data Supporting the Cardiovascular Safety of Qsymia vivus.com ↗
Results show that the risk of major adverse cardiovascular events (MACE) trended lower in patients taking Qsymia compared with similar patients who were not taking Qsymia. |
| 2017-03-30 | Upsher-Smith Laboratories | Regulatory FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules upsher-smith.com ↗
Upsher-Smith Laboratories, Inc. (Upsher-Smith) today announced that it has received U.S. Food and Drug Administration (FDA) final approval of two supplemental new drug applications (sNDAs) for Qudexy® XR (topiramate) Extended-Release Capsules for use as prophylaxis of migraine headache in adults and adolescents 12 years of age and older. |
| 2013-07-26 | Ligand Pharmaceuticals | Regulatory Ligand Receives Orphan Designation for Captisol-EnabledTM Topiramate Injection ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for its proprietary Captisol-enabled™ Topiramate Injection for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized epilepsy patients who are unable to take oral topiramate. |
| 2009-03-28 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval to market generic Topamax® tablets sunpharma.com ↗
Sun Pharma announces USFDA approval to market generic Topamax ® tablets |
| 2009-03-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval and Launch of Generic Topamax® Tablets tevapharm.com ↗ |
| 2006-03-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Topiramate Tablets, 50 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Topiramate Tablets, 50 mg. |
All press releases naming this drug 29 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 292 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | topiramate | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗272“Results from a previously conducted global phase III study (PREVAIL; NCT01142193) demonstrate the safety and efficacy of once-daily USL255, Qudexy™ XR (topiramate)...” PMID 25461205 ↗ Oct 2014 “Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily...” NCT00806260 ↗ “OBJECTIVE: The aim of this study was to evaluate long-term safety, efficacy, and quality of life (QOL) of ≤400-mg/day USL255, Qudexy® XR (topiramate) extended-release capsules,...” PMID 27084978 ↗ Apr 2016 “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely...” NCT03280342 ↗ “Pharmacological prophylaxis will be prescribed based on patients' profile (e.g. previous failures or contraindications), and limited to Topiramate, Propanolol, Amytriptiline or...” NCT03461874 ↗ “List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery” NCT04613024 ↗ “The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome” NCT00241995 ↗ “This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight” NCT05834062 ↗ |
| Known as | 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate | “Topiramate is an anticonvulsant (antiepilepsy) drug. IUPAC ID: 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate” NCT05975580 ↗ |
| Known as | Epitomax | “An alternative therapeutic approach for behavioral disturbances has been suggested by some authors with topiramate (Epitomax®), an antiepileptic drug that can be used as a mood...” NCT02810483 ↗ |
| Known as | IR-TPM | “The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely...” NCT03280342 ↗ |
| Known as | JNS019 | “Topiramate (JNS019) 50 mg” NCT01081795 ↗ |
| Known as | Qudexy XR | “Results from a previously conducted global phase III study (PREVAIL; NCT01142193) demonstrate the safety and efficacy of once-daily USL255, Qudexy™ XR (topiramate)...” PMID 25461205 ↗ Oct 20141“OBJECTIVE: The aim of this study was to evaluate long-term safety, efficacy, and quality of life (QOL) of ≤400-mg/day USL255, Qudexy® XR (topiramate) extended-release capsules,...” PMID 27084978 ↗ Apr 2016 |
| Known as | RWJ-17021 | “Multiple Oral Daily Topiramate (RWJ-17021) Dosing” NCT00986128 ↗ |
| Known as | RWJ-17021-000 | “An Open-Label, Randomized, 2-Way Crossover Study of the Bioavailability of an Oral Liquid Formulation Relative to the Marketed Sprinkle Capsule Formulation of Topiramate...” NCT00701493 ↗1“Topiramate (RWJ 17021-000) Clinical Trial In Children With Partial Onset Seizures” NCT00236743 ↗ |
| Known as | TOP | “Topiramate (TOP) blocks glutamate receptors and facilitates GABA (γ-aminobutyric acid) neurotransmission” PMID 24057996 ↗ Sep 2013 |
| Known as | Topamax | “The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely...” NCT03280342 ↗20“The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of Topiramate (Topamax) added to an SSRI for the management...” NCT00211744 ↗ “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗ “The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets...” NCT00905606 ↗ “The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets...” NCT00905567 ↗ “Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Capsules and Topamax® 25 mg Capsules Administered as 2 x 25 mg Capsules in Healthy Subjects Under Fed Conditions” NCT00904943 ↗ “Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers” NCT00649740 ↗ “Single-Dose Fed Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers” NCT00648934 ↗ “Topiramate (marketed under the brand name Topamax) is approved by the U.S. FDA for the prevention of migraine headaches in adults.” NCT00393978 ↗ “Single Center TOPAMAX� (Topiramate) Monotherapy Trial in Subjects With Refractory Partial Onset Seizures” NCT00266591 ↗ “TOPAMAX® (topiramate) is initiated as monotherapy and titrated to an individualized optimal dose.” NCT00266604 ↗ |
| Known as | TPM | “The safety and efficacy of treatment with phentermine
(PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were...” PMID 25249652 ↗ Sep 201416“A total of 131 adults and children (mean age, 27 years; range, 3-59 years) with generalized tonic-clonic seizures (GTCS) of nonfocal origin resistant to other antiepileptic...” PMID 10768306 ↗ 2000 “PURPOSE: We wished to evaluate adjunctive therapy for partial-onset seizures with topiramate (TPM) for efficacy and safety in a double-blind, placebo-controlled, randomized,...” PMID 8764816 ↗ Aug 1996 “Several large, randomized, double-blind, placebo-controlled trials have found topiramate (TPM) to be effective and generally well tolerated as a preventive therapy for migraine.” PMID 16990078 ↗ Jul 2006 “The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery” NCT04613024 ↗ “Topiramate (TPM, an antiepileptic drug) is, with increasing frequency, being prescribed for a range of conditions including migraine prophylaxis, obesity and pain.” NCT01889602 ↗ “In a double-blind, randomized, parallel-group trial, we compared topiramate (TPM) with placebo as add-on therapy in patients with refractory partial epilepsy.” PMID 8641230 ↗ Jun 1996 “To evaluate the efficacy of adjunctive topiramate (TPM) for the treatment of cannabis use disorder in adolescents with bipolar I disorder.” PMID 39697396 ↗ Sep 2024 “OBJECTIVE: To examine the safety and efficacy of topiramate (TPM) for maintaining weight following a low-calorie diet.” PMID 15536230 ↗ Oct 2004 “To evaluate topiramate (TPM) and phenytoin (PHT) monotherapy following rapid oral initiation in new-onset epilepsy.” PMID 20633037 ↗ Oct 2010 “Topiramate (TPM) has shown efficacy in migraine prophylaxis in two large placebo-controlled, dose-ranging trials.” PMID 15316798 ↗ Aug 2004 |
| Known as | TPMT | “Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking.” NCT00884884 ↗ |
| Known as | Trokendi XR | “The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely...” NCT03280342 ↗ |
| Known as | Tuotai Pian | “Topiramate 25Mg Tab (Tuotai Pian, Xian Janssen Pharmaceutical Ltd.) are prescribed to participates by one neurologist.” NCT05516251 ↗ |
| Known as | USL255 | “Results from a previously conducted global phase III study (PREVAIL; NCT01142193) demonstrate the safety and efficacy of once-daily USL255, Qudexy™ XR (topiramate)...” PMID 25461205 ↗ Oct 2014 |
| Known as | XR-TPM | “The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely...” NCT03280342 ↗ |
| Action | Inhibit | “Topiramate inhibits glutamatergic conduction.” PMID 20816027 ↗ Aug 2010 |
| Modality | Small molecule | “Topiramate (a sulfamate-substituted fructo-pyranose derivative)” NCT00223639 ↗ |
| Route | Oral | “oral topiramate” NCT00004776 ↗ |
| Target | GRINA | “GRINA, PRKACA, PRKCI, SNAP23, and TRAK2, which are involved in glutamate receptor and GABA receptor signaling, are direct targets for TPM.” PMID 25495887 ↗ Dec 2014 |
| Target | PRKACA | “GRINA, PRKACA, PRKCI, SNAP23, and TRAK2, which are involved in glutamate receptor and GABA receptor signaling, are direct targets for TPM.” PMID 25495887 ↗ Dec 2014 |
| Target | PRKCI | “GRINA, PRKACA, PRKCI, SNAP23, and TRAK2, which are involved in glutamate receptor and GABA receptor signaling, are direct targets for TPM.” PMID 25495887 ↗ Dec 2014 |
| Target | SNAP23 | “GRINA, PRKACA, PRKCI, SNAP23, and TRAK2, which are involved in glutamate receptor and GABA receptor signaling, are direct targets for TPM.” PMID 25495887 ↗ Dec 2014 |
| Target | TRAK2 | “GRINA, PRKACA, PRKCI, SNAP23, and TRAK2, which are involved in glutamate receptor and GABA receptor signaling, are direct targets for TPM.” PMID 25495887 ↗ Dec 2014 |