MedPath

Imipramine

Generic Name
Imipramine
Brand Names
Tofranil
Drug Type
Small Molecule
Chemical Formula
C19H24N2
CAS Number
50-49-7
Unique Ingredient Identifier
OGG85SX4E4

Overview

Imipramine, the prototypical tricyclic antidepressant (TCA), is a dibenzazepine-derivative 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, imipramine does not affect mood or arousal, but may cause sedation. In depressed individuals, imipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as imipramine and amitriptyline, are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline and desipramine. 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 . Imipramine has less sedative and anticholinergic effects than the tertiary amine TCAs, amitriptyline and clomipramine. Imipramine may be used to treat depression and nocturnal enuresis in children . Unlabeled indications include chronic and neuropathic pain (including diabetic neuropathy), panic disorder, attention-deficit/hyperactivity disorder (ADHD), and post-traumatic stress disorder (PTSD) .

Indication

For the relief of symptoms of depression and as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older . May also be used off-label to manage panic disorders with or without agoraphobia, as a second line agent for ADHD in children and adolescents, to manage bulimia nervosa, for short-term management of acute depressive episodes in bipolar disorder and schizophrenia, for the treatment of acute stress disorder and posttraumatic stress disorder, and for symptomatic treatment of postherpetic neuralgia and painful diabetic neuropathy .

Associated Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Bulimia Nervosa
  • Depression
  • Enuresis
  • Neuropathic Pain
  • Panic Disorder

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/16
Phase 2
Recruiting
2024/07/12
Not Applicable
Recruiting
2024/03/15
Phase 2
Recruiting
2023/01/18
Phase 1
Recruiting
2023/01/10
Phase 3
Recruiting
2021/04/28
Phase 2
Recruiting
2020/08/20
Phase 1
Recruiting
2020/06/02
Phase 3
Withdrawn
2019/05/22
Early Phase 1
Withdrawn
2017/04/20
Early Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Hikma Pharmaceuticals USA Inc
0054-0273
ORAL
75 mg in 1 1
2/3/2017
REMEDYREPACK INC.
70518-3438
ORAL
50 mg in 1 1
1/11/2024
PD-Rx Pharmaceuticals, Inc.
72789-243
ORAL
25 mg in 1 1
9/25/2023
NuCare Pharmaceuticals,Inc.
68071-2730
ORAL
50 mg in 1 1
5/23/2022
Par Pharmaceutical, Inc.
49884-054
ORAL
10 mg in 1 1
9/12/2023
Leading Pharma, LLC
69315-133
ORAL
10 mg in 1 1
10/28/2022
REMEDYREPACK INC.
70518-3526
ORAL
25 mg in 1 1
1/15/2024
Lupin Pharmaceuticals, Inc.
68180-316
ORAL
125 mg in 1 1
11/1/2023
Leading Pharma, LLC
69315-135
ORAL
50 mg in 1 1
10/28/2022
PD-Rx Pharmaceuticals, Inc.
72789-244
ORAL
50 mg in 1 1
9/25/2023

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
AA PHARMA IMIPRAMINE TABLET 25MG
SIN04154P
TABLET, FILM COATED
25 mg
4/20/1990
AA PHARMA IMIPRAMINE TABLET 10MG
SIN04155P
TABLET, FILM COATED
10 mg
4/20/1990

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Imipramine Hydrochloride tablets
国药准字H19994048
化学药品
片剂(糖衣片)
1/15/2020
Imipramine Hydrochloride tablets
国药准字H31021201
化学药品
片剂(糖衣)
2/26/2020
Imipramine Hydrochloride tablets
国药准字H31020406
化学药品
片剂
2/26/2020
Imipramine Hydrochloride tablets
国药准字H31021551
化学药品
片剂(糖衣)
12/4/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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