Last update 18 Nov 2024

Bromhexine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
3,5-dibromo-N(alpha)-cyclohexyl-N(alpha)-methyltoluene-alpha-2-diamine, Bromexine Hydrochloride, Bromhexine
+ [11]
Target-
Mechanism-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US)
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Structure

Molecular FormulaC14H21Br2ClN2
InChIKeyUCDKONUHZNTQPY-UHFFFAOYSA-N
CAS Registry611-75-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Acute Bronchitis
JP
29 Mar 1991
Bronchitis, Chronic
JP
29 Mar 1991
Sputum excretion difficulty
JP
01 Nov 1980
Pneumoconiosis
JP
01 Nov 1976
Pulmonary Tuberculosis
JP
01 Nov 1976
Respiratory Tract Infections--01 Jan 1963
Xerophthalmia--01 Jan 1963
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute sinusitisPhase 3
CN
06 Jul 2021
Chronic bronchial diseasePhase 3
CN
06 Jul 2021
Chronic sinusitisPhase 3
CN
06 Jul 2021
Lower Respiratory Tract InfectionsPhase 3
CN
06 Jul 2021
TracheobronchitisPhase 3
CN
06 Jul 2021
BronchiectasisPhase 3
CN
07 Apr 2021
BronchopneumoniaPhase 3
CN
07 Apr 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
50
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-
13 Apr 2022
(Bromhexine Hydrochloride Group)
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Approval

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Regulation

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