Drugs / Tiagabine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) GABITRIL — 1997-09-30 fda.gov ↗

Trials 11

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01904487 Apr 2011 → Oct 2013 alcohol dependence Rajesh Narendran Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00129298 Dec 2004 → Apr 2007 cocaine dependence, opiate dependence National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 2 NCT00086255 Oct 2002 → Jun 2004 cocaine dependence National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 35 trials
Phase 3 NCT00214994 Jan 2005 → Dec 2006 anxiety disorder Cephalon Completed No outcome recorded
Phase 3 NCT00236015 Nov 2004 → Mar 2006 anxiety disorder Cephalon Completed No outcome recorded
Phase 3 NCT00236067 Oct 2004 → Mar 2006 generalized anxiety disorder Cephalon Completed No outcome recorded
Phase 3 NCT00236054 Oct 2004 → Dec 2005 generalized anxiety disorder Cephalon Completed No outcome recorded
Phase 3 NCT00233675 Aug 2003 → Feb 2005 generalized anxiety disorder Cephalon Completed No outcome recorded
Phase 43 trials
Phase 4 NCT00855738 May 2007 → Jun 2009 focal epilepsy Viatris Inc. Completed No outcome recorded
Phase 4 NCT00174850 Jul 2004 → May 2005 anxiety, sexual disorder State University of New York - Upstate Medical University Completed No outcome recorded
Phase 4 NCT00208741 Jun 2002 → Nov 2003 social phobia Emory University Completed No outcome recorded
Comparator or background therapy4 trials
Phase 2 NCT02387710 Comparator Mar 2015 → Jun 2016 obstructive sleep apnea syndrome Brigham and Women's Hospital Completed No outcome recorded
Phase 2 NCT00218166 Comparator Aug 2001 → May 2005 cocaine abuse National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 3 NCT00179465 Comparator Nov 2003 → Sep 2026 overdue schizophrenia Beth Israel Deaconess Medical Center Active not recruiting No outcome recorded
Phase 4 NCT00552526 Comparator Nov 2007 → Jan 2011 epilepsy Oslo University Hospital Unknown No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2018-03-12 Impax Laboratories, LLC Amneal Launches Generic for Gabitril® amneal.com ↗

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as tiagabine “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗
10

“A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With...” NCT00208741 ↗

“Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI) that is FDA approved to treat certain types of epilepsy.” NCT00174850 ↗

“Triazolam, tiagabine, baclofen” NCT00218166 ↗

NCT00855738 ↗

NCT01904487 ↗

NCT00179465 ↗

NCT00086255 ↗

NCT00233675 ↗

NCT00129298 ↗

NCT02387710 ↗

Known as A-70569-1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABBOTT-70569 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABBOTT-70569 HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABBOTT-70569.1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABBOTT-70569.HCL ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABBOTT-705691 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABT-569 ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as ABT-569 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as CEP-6671 “GABITRIL (tiagabine hydrochloride; CEP-6671)” NCT00233675 ↗
Known as Gabatril ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as Gabitril “A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With...” NCT00208741 ↗
8

“After the first PET scan, you will be given an oral dose of tiagabine (Gabitril®), which is a medication approved for the treatment of seizure disorder.” NCT01904487 ↗

“Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction” NCT00174850 ↗

“treatment with tiagabine (Gabitril) during the early course of schizophrenia” NCT00179465 ↗

“GABITRIL (tiagabine hydrochloride; CEP-6671)” NCT00233675 ↗

NCT00236067 ↗

NCT00236054 ↗

NCT00236015 ↗

NCT00214994 ↗

Known as NNC-05-0328 ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as NNC-050328 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as NO-05-0328 ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as NO-050328 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as Tiagabina ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as Tiagabine hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL1027 ↗
Known as Tiagabine Hydrochloride “A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With...” NCT00208741 ↗
1

“GABITRIL (tiagabine hydrochloride; CEP-6671)” NCT00233675 ↗

Action Inhibit “a GABA transporter GAT-1-specific inhibitor” NCT00179465 ↗
1

“GABA transporter 1 inhibitor” CHEMBL1027 ↗

Modality Small molecule — CHEMBL1027 ↗
Route Oral “After the first PET scan, you will be given an oral dose of tiagabine (Gabitril®), which is a medication approved for the treatment of seizure disorder.” NCT01904487 ↗
Target SLC6A1 “GABA transporter 1 inhibitor” CHEMBL1027 ↗