Overview
Clomipramine, the 3-chloro analog of imipramine, is a dibenzazepine-derivative tricyclic antidepressant (TCA). TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, clomipramine does not affect mood or arousal, but may cause sedation. In depressed individuals, clomipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as clomipramine, are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline and desipramine. TCAs also down-regulate cerebral cortical β-adrenergic receptors and sensitize post-synaptic serotonergic receptors with chronic use. The antidepressant effects of TCAs are thought to be due to an overall increase in serotonergic neurotransmission. TCAs also block histamine-H receptors, α-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively. See toxicity section below for a complete listing of side effects. Clomipramine may be used to treat obsessive-compulsive disorder and disorders with an obsessive-compulsive component (e.g. depression, schizophrenia, Tourette’s disorder). Unlabeled indications include panic disorder, chronic pain (e.g. central pain, idiopathic pain disorder, tension headache, diabetic peripheral neuropathy, neuropathic pain), cataplexy and associated narcolepsy, autistic disorder, trichotillomania, onchophagia, stuttering, premature ejaculation, and premenstrual syndrome. Clomipramine is rapidly absorbed from the gastrointestinal tract and demethylated in the liver to its primary active metabolite, desmethylclomipramine.
Background
Clomipramine, the 3-chloro analog of imipramine, is a dibenzazepine-derivative tricyclic antidepressant (TCA). TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, clomipramine does not affect mood or arousal, but may cause sedation. In depressed individuals, clomipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as clomipramine, are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline and desipramine. TCAs also down-regulate cerebral cortical β-adrenergic receptors and sensitize post-synaptic serotonergic receptors with chronic use. The antidepressant effects of TCAs are thought to be due to an overall increase in serotonergic neurotransmission. TCAs also block histamine-H receptors, α-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively. See toxicity section below for a complete listing of side effects. Clomipramine may be used to treat obsessive-compulsive disorder and disorders with an obsessive-compulsive component (e.g. depression, schizophrenia, Tourette’s disorder). Unlabeled indications include panic disorder, chronic pain (e.g. central pain, idiopathic pain disorder, tension headache, diabetic peripheral neuropathy, neuropathic pain), cataplexy and associated narcolepsy, autistic disorder, trichotillomania, onchophagia, stuttering, premature ejaculation, and premenstrual syndrome. Clomipramine is rapidly absorbed from the gastrointestinal tract and demethylated in the liver to its primary active metabolite, desmethylclomipramine.
Indication
May be used to treat obsessive-compulsive disorder and disorders with an obsessive-compulsive component (e.g. depression, schizophrenia, Tourette’s disorder). Unlabeled indications include: depression, panic disorder, chronic pain (e.g. central pain, idiopathic pain disorder, tension headache, diabetic peripheral neuropathy, neuropathic pain), cataplexy and associated narcolepsy (limited evidence), autistic disorder (limited evidence), trichotillomania (limited evidence), onchophagia (limited evidence), stuttering (limited evidence), premature ejaculation, and premenstrual syndrome.
Associated Conditions
- Depression
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated | |||
2013/07/11 | Not Applicable | UNKNOWN | |||
2012/04/11 | Not Applicable | Completed | |||
2011/09/23 | Phase 3 | Completed | |||
2011/07/28 | Not Applicable | Completed | |||
2010/09/16 | Phase 2 | Completed | |||
2009/06/04 | Phase 1 | Completed | |||
2007/11/28 | Phase 4 | Completed | |||
2007/04/27 | Phase 4 | Completed | |||
1999/10/19 | Phase 2 | UNKNOWN | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Mizner Bioscience, LLC | 86039-114 | ORAL | 20 mg in 1 1 | 5/27/2025 | |
Alembic Pharmaceuticals Inc. | 62332-409 | ORAL | 75 mg in 1 1 | 10/12/2021 | |
TruPharma LLC | 52817-281 | ORAL | 50 mg in 1 1 | 11/17/2022 | |
Zydus Lifesciences Limited | 70771-1013 | ORAL | 50 mg in 1 1 | 9/21/2023 | |
Covetrus North America | 11695-6952 | ORAL | 40 mg in 1 1 | 5/27/2025 | |
Alembic Pharmaceuticals Limited | 46708-407 | ORAL | 25 mg in 1 1 | 1/27/2023 | |
Lupin Pharmaceuticals, Inc. | 68180-493 | ORAL | 50 mg in 1 1 | 10/31/2023 | |
MWI/VetOne | 13985-975 | ORAL | 20 mg in 1 1 | 5/27/2025 | |
SpecGx LLC | 0406-9908 | ORAL | 75 mg in 1 1 | 11/29/2023 | |
Golden State Medical Supply, Inc. | 51407-757 | ORAL | 25 mg in 1 1 | 4/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
APO-CLOMIPRAMINE TABLET 25 mg | SIN09018P | TABLET, FILM COATED | 25 mg | 11/28/1996 | |
APO-CLOMIPRAMINE TABLET 10 mg | SIN09058P | TABLET, FILM COATED | 10 mg | 12/9/1996 | |
DEPRANIL TABLET 25 mg | SIN09611P | TABLET | 25 mg | 1/26/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Clomipramine Hydrochloride Injection | 国药准字H20055612 | 化学药品 | 注射剂 | 7/14/2020 | |
Clomipramine Hydrochloride Injection | 国药准字H10910016 | 化学药品 | 注射剂 | 3/22/2021 | |
Clomipramine Hydrochloride Tablets | 国药准字H11022409 | 化学药品 | 片剂 | 11/9/2020 | |
Clomipramine Hydrochloride Tablets | 国药准字H10920086 | 化学药品 | 片剂 | 7/26/2022 | |
Clomipramine Hydrochloride Tablets | 国药准字H10900027 | 化学药品 | 片剂(薄膜衣) | 6/10/2020 | |
Clomipramine Hydrochloride Tablets | 国药准字H31021286 | 化学药品 | 片剂(糖衣) | 12/23/2019 | |
Clomipramine Hydrochloride Tablets | 国药准字H11022404 | 化学药品 | 片剂(糖衣) | 11/18/2020 | |
Clomipramine Hydrochloride Tablets | 国药准字H12020277 | 化学药品 | 片剂 | 3/27/2020 | |
Clomipramine Hydrochloride Tablets | 国药准字H32022975 | 化学药品 | 片剂 | 7/14/2020 | |
Clomipramine Hydrochloride Tablets | 国药准字H31022082 | 化学药品 | 片剂(糖衣) | 1/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Anafranil Tablets | 10987 | Pharmaco Australia Ltd | Medicine | A | 8/2/1991 |
PLACIL clomipramine hydrochloride 25mg tablet blister pack | 143879 | Medicine | A | 9/18/2007 | |
APO-CLOMIPRAMINE clomipramine hydrochloride 25mg tablet blister pack | 73878 | Medicine | A | 6/7/2000 | |
CLOMIPRAMINE-WGR clomipramine hydrochloride 25mg tablet blister pack | 423112 | Medicine | A | 1/3/2024 | |
CLOMIPRAMINE-RJIC clomipramine hydrochloride 25mg tablet blister pack | 423113 | Medicine | A | 1/3/2024 |