Last update 20 Mar 2025

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
+ [14]
Target-
Action-
Mechanism-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC14H21Br2ClN2
InChIKeyUCDKONUHZNTQPY-UHFFFAOYSA-N
CAS Registry611-75-6
View All Structures (2)

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Acute Bronchitis
Japan
29 Mar 1991
Bronchitis, Chronic
Japan
29 Mar 1991
Sputum excretion difficulty
Japan
01 Nov 1980
Pneumoconiosis
Japan
01 Nov 1976
Pulmonary Tuberculosis
Japan
01 Nov 1976
Respiratory Tract Infections--01 Jan 1963
Xerophthalmia--01 Jan 1963
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute BronchitisPhase 3
China
20 Mar 2023
PneumoconiosisPhase 3
China
20 Mar 2023
Acute sinusitisPhase 3
China
06 Jul 2021
Bronchitis, ChronicPhase 3
China
06 Jul 2021
Chronic bronchial diseasePhase 3
China
06 Jul 2021
Chronic sinusitisPhase 3
China
06 Jul 2021
Lower Respiratory Tract InfectionsPhase 3
China
06 Jul 2021
TracheobronchitisPhase 3
China
06 Jul 2021
BronchiectasisPreclinical
China
07 Apr 2021
BronchopneumoniaPreclinical
China
07 Apr 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
50
qbknmfcmch(ixmygicgyx) = zjudwnssvx qtvkdopbih (lypguhwqii, yxbjodutbr - uwppndasqe)
-
13 Apr 2022
(Bromhexine Hydrochloride Group)
tgyshjibce(roqforfktg) = hwkflcxbit ivqejykoof (erzwbmqamn, mnlpyymdah - fnyygnyaab)
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Clinical Trial

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Approval

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Regulation

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