Drugs / Clomipramine
Clomipramine
also known as
Anafranil · Clomipramine Hydrochloride · Anafranil sr · Ananfranil · Anapramine · Chlorimipramine · Clomicalm · Clomipramina · +6 more
Small molecule targets SLC6A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ANAFRANIL | — | 1989-12-29 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| Comparator or background therapy12 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 4 | NCT01305707 Comparator | Jul 2009 → Jul 2014 | major depressive disorder | Hospital Universitari de Bellvitge | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00466609 Comparator | May 2007 → Mar 2010 | obsessive-compulsive disorder | University of Sao Paulo | Completed | Missed primary |
| Phase 4 | NCT00564564 Comparator | Jan 2006 → Dec 2007 | obsessive-compulsive disorder | University of Sao Paulo | Completed | No outcome recorded |
| — | 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 Stop: Enrollment |
| — | 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 |
| — | NCT01404871 Comparator | Apr 2009 → Oct 2011 | obsessive-compulsive disorder | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| — | NCT01575158 Comparator | Oct 1997 → Sep 2007 | depressive disorder | University of Aarhus | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-08-01 | Alembic Pharmaceuticals Ltd. | Regulatory 5th August, 2021, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg. |
| 2018-12-05 | Lupin Limited | Regulatory Lupin receives FDA approval for Clomipramine HCl Capsules lupin.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-01 | Alembic Pharmaceuticals Ltd. | 5th August, 2021, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2019-02-05 | Lupin Limited | Lupin launches Clomipramine Hydrochloride Capsules USP lupin.com ↗ |
| 2018-12-05 | Lupin Limited | Lupin receives FDA approval for Clomipramine HCl Capsules lupin.com ↗ |
| 2017-03-22 | Upsher-Smith Laboratories | Upsher-Smith Announces the Launch of Generic Clomipramine upsher-smith.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited 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, clomipramine” NCT02431845 ↗ “Clomipramine HCl 15mg (Condencia Tab)” NCT02028598 ↗ “Clomipramine (Ananfranil and others)” NCT01944657 ↗ “- Clomipramine 75-225 mg/d. N06AA04” NCT01305707 ↗ “Clomipramine (Anafranil)25-200;” NCT00074815 ↗ |
| 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 ↗ “anafranil” NCT00944996 ↗ |
| 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 ↗ |