Drugs / Clomipramine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ANAFRANIL 1989-12-29 fda.gov

Trials 10 · a red edge is where a trial was stopped

19891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029203020312032
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT02028598 Jan → Mar 2014 CTC Bio, Inc. Completed No outcome recorded
Phase 1 NCT00913952 Apr → Jun 1994 depressive disorder Sandoz Completed No outcome recorded
Phase 1 NCT00913783 Nov → Dec 1992 depressive disorder Sandoz Completed No outcome recorded
Phase 23 trials
Phase 2 NCT02571101 Nov 2015 → May 2016 premature ejaculation CTC Bio, Inc. Unknown No outcome recorded
Phase 2 NCT01203202 Sep 2010 → Jan 2011 premature ejaculation Symyoo Completed No outcome recorded
Phase 2 NCT00004310 Oct 1999 → ? obsessive-compulsive disorder National Center for Research Resources (NCRR) Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 3 NCT01439984 Sep 2011 → Jun 2012 premature ejaculation Symyoo Completed No outcome recorded
Phase 41 trial
Phase 4 NCT03548675 May 2018 → Feb 2022 major depressive disorder Radboud University Medical Center Completed No outcome recorded
Phase not applicable1 trial
NCT02431845 Jan 2013 → Dec 2030 expected obsessive-compulsive disorder Severance Hospital Recruiting No outcome recorded
Also used as a comparator or background therapy in 12 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials
Phase 3 NCT00074815 Background Sep 2003 → Nov 2009 obsessive-compulsive disorder Duke University Completed No outcome recorded
Phase 3 NCT00254735 Background Apr 2002 → Mar 2006 obsessive-compulsive disorder AstraZeneca Completed No outcome recorded
Phase 43 trials
Phase 4 NCT01305707 Comparator Jul 2009 → Jul 2014 major depressive disorder Hospital Universitari de Bellvitge Terminated No outcome recorded
Phase 4 NCT00466609 Comparator May 2007 → Mar 2010 obsessive-compulsive disorder University of Sao Paulo Completed No outcome recorded
Phase 4 NCT00564564 Comparator Jan 2006 → Dec 2007 obsessive-compulsive disorder University of Sao Paulo Completed No outcome recorded
Phase not applicable7 trials
NCT06942494 Comparator Apr 2025 → Aug 2027 expected obsessive-compulsive disorder Shanghai Mental Health Center Recruiting No outcome recorded
NCT06659094 Background Aug 2023 → Aug 2025 obsessive-compulsive disorder Shanghai Mental Health Center Completed No outcome recorded
NCT01944657 Comparator Sep 2013 → Dec 2015 major depressive disorder Sheppard Pratt Health System Withdrawn No outcome recorded
NCT01896349 Background Apr 2013 → Aug 2014 Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
NCT00944996 Comparator Jun 2009 → Jun 2010 major depressive disorder Tirat Carmel Mental Health Center Completed No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as clomipramine “In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine)...” NCT06942494
20

“These include fluoxetine, paroxetine, sertraline, fluvoxamine, and others, with tricyclic drugs like clomipramine and SNRIs such as venlafaxine.” NCT06659094

Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent inhibitor of serotonin and norepinephrine reuptake.” NCT02571101

“Patients were treated with the TCAs nortriptyline, clomipramine, or imipramine, with clinical follow-up of 7 weeks.” PMID 37155164 May 2023

“fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramineNCT02431845

Clomipramine HCl 15mg (Condencia Tab)” NCT02028598

Clomipramine (Ananfranil and others)” NCT01944657

“- Clomipramine 75-225 mg/d. N06AA04” NCT01305707

Clomipramine (Anafranil)25-200;” NCT00074815

NCT00913952

NCT01404871

NCT00466609

NCT01203202

NCT00913783

NCT00254735

NCT01575158

NCT01439984

NCT02374567

NCT01896349

NCT00564564

NCT00004310

Known as Anafranil “Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions” NCT00913952
3

Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)” NCT00913783

“Clomipramine (Anafranil)25-200;” NCT00074815

anafranilNCT00944996

Known as Anafranil sr ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as Ananfranil “Clomipramine (Ananfranil and others)” NCT01944657
Known as Anapramine ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as Chlorimipramine ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as Clomicalm ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as Clomipramina ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as Clomipramine HCl Clomipramine HCl 15mg” NCT02571101
Known as Clomipramine Hydrochloride “Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions” NCT00913952
1

Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)” NCT00913783

Known as CMI “intravenous versus oral pulse loading of clomipramine (CMI) followed by a 12-week course of maintenance therapy” NCT00004310
Known as G 34586 ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as NSC-169865 ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as NSC-759323 ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Known as Tranquax ChEMBL registry synonym — accepted as the source's own label CHEMBL415
Action Inhibit “Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent inhibitor of serotonin and norepinephrine reuptake.” NCT02028598
1

“Serotonin transporter inhibitor” CHEMBL415

Modality Small molecule CHEMBL415
Route Intravenous “pulse loading dose of clomipramine (CMI) IV” NCT00004310
Target SLC6A4 “Serotonin transporter inhibitor” CHEMBL415