MedPath

Desipramine

Generic Name
Desipramine
Brand Names
Norpramin
Drug Type
Small Molecule
Chemical Formula
C18H22N2
CAS Number
50-47-5
Unique Ingredient Identifier
TG537D343B

Overview

Desipramine hydrochloride 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, desipramine does not affect mood or arousal, but may cause sedation. In depressed individuals, desipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Secondary amine TCAs, such as desipramine and nortriptyline, are more potent inhibitors of norepinephrine reuptake than tertiary amine TCAs, such as amitriptyline and doxepine. 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. Desipramine exerts less anticholinergic and sedative side effects compared to tertiary amine TCAs, such as amitriptyline and clomipramine. Desipramine may be used to treat depression, neuropathic pain (unlabeled use), agitation and insomnia (unlabeled use) and attention-deficit hyperactivity disorder (unlabeled use).

Indication

For relief of symptoms in various depressive syndromes, especially endogenous depression. It has also been used to manage chronic peripheral neuropathic pain, as a second line agent for the management of anxiety disorders (e.g. panic disorder, generalized anxiety disorder), and as a second or third line agent in the ADHD management.

Associated Conditions

  • Anorexia Nervosa (AN)
  • Bulimia Nervosa
  • Chronic Pain
  • Depression
  • Diabetic Neuropathies
  • Insomnia
  • Irritable Bowel Syndrome (IBS)
  • Neuropathic Pain
  • Panic Disorder
  • Postherpetic Neuralgia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2018/11/01
Phase 4
Terminated
2018/06/07
Phase 4
Recruiting
2015/05/06
Phase 2
Completed
2015/04/28
Phase 2
Completed
2014/10/24
Phase 1
Completed
2013/07/15
Not Applicable
Terminated
2012/11/01
Phase 2
Terminated
Joel Neal
2011/11/23
Phase 1
Completed
2011/08/11
Phase 1
Completed
2011/05/24
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Ingenus Pharmaceuticals, LLC
50742-114
ORAL
50 mg in 1 1
6/22/2023
Alembic Pharmaceuticals Inc.
62332-320
ORAL
150 mg in 1 1
10/12/2021
Bryant Ranch Prepack
71335-1021
ORAL
10 mg in 1 1
11/9/2021
Alembic Pharmaceuticals Inc.
62332-316
ORAL
25 mg in 1 1
10/12/2021
Alembic Pharmaceuticals Inc.
62332-319
ORAL
100 mg in 1 1
10/12/2021
Actavis Pharma, Inc.
45963-344
ORAL
75 mg in 1 1
12/26/2023
Amneal Pharmaceuticals NY LLC
69238-1055
ORAL
25 mg in 1 1
3/15/2023
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-583
ORAL
150 mg in 1 1
8/26/2025
INDICUS PHARMA LLC
24724-071
ORAL
100 mg in 1 1
7/21/2016
Alembic Pharmaceuticals Inc.
62332-315
ORAL
10 mg in 1 1
10/12/2021

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
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS DESIPRAMINE HYDRO TAB 50MG
01946277
Tablet - Oral
50 MG
12/31/1993
DOM-DESIPRAMINE TABLETS - 25MG
dominion pharmacal
02130092
Tablet - Oral
25 MG
12/31/1996
NOVO-DESIPRAMINE FC - 50MG TAB
novopharm limited
02223333
Tablet - Oral
50 MG
11/27/1996
NORPRAMIN 25MG TAB
sanofi-aventis canada inc
02099128
Tablet - Oral
25 MG
12/31/1995
NORPRAMIN TAB 25MG
merrell pharms inc., division of merrell dow (can)
00353868
Tablet - Oral
25 MG / TAB
12/31/1976
PMS DESIPRAMINE HYDRO TAB 10MG
01946250
Tablet - Oral
10 MG
12/31/1993
PENTA-DESIPRAMINE TABLETS
pentapharm ltd.
02232563
Tablet - Oral
75 MG / TAB
N/A
NOVO-DESIPRAMINE SC - TAB 25MG
novopharm limited
02223325
Tablet - Oral
25 MG
11/27/1996
DESIPRAMINE
aa pharma inc
02216256
Tablet - Oral
25 MG
12/31/1996
DESIPRAMINE
aa pharma inc
02216280
Tablet - Oral
100 MG
12/31/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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