Overview
Bromhexine is mucolytic agent used for a variety of respiratory conditions associated with increased mucus secretion. It is derived from the Adhatoda vasica plant and aids in the clearance of excess mucus, improving breathing and reducing cough. It was introduced into the market in 1963, and is widely available as an over-the-counter drug in many countries. Recently, bromhexine and its metabolite ambroxol have garnered interest for the potential prevention and treatment of COVID-19 due to their interactions with cell receptors in the lungs.
Indication
Bromohexine is used alone or with other ingredients such as diphenhydramine, dextromethorphan, and guaifenesin to reduce mucus viscosity and clear mucus in conditions associated with mucus hypersecretion, including the common cold, influenza, respiratory tract infections, or other conditions.
Associated Conditions
- Bronchiectasis
- Common Cold
- Cough
- Cough caused by Common Cold
- Nasal Congestion
- Whooping Cough
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/17 | Phase 1 | Completed | Second Affiliated Hospital of Wenzhou Medical University | ||
2020/06/09 | Phase 3 | UNKNOWN | Lomonosov Moscow State University Medical Research and Educational Center | ||
2020/05/28 | Phase 4 | Completed | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | ||
2020/04/21 | Phase 4 | UNKNOWN | General and Teaching Hospital Celje | ||
2020/04/09 | Early Phase 1 | UNKNOWN | |||
2020/02/18 | Not Applicable | UNKNOWN | Second Affiliated Hospital of Wenzhou Medical University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| VASICAN TABLET 8 mg | SIN02528P | TABLET | 8 mg | 4/18/1989 | |
| BROMXINE TABLET 8 mg | ATLANTIC LABORATORIES CORPN LTD | SIN09127P | TABLET | 8 mg | 1/13/1997 |
| VASICAN SYRUP 4 MG/5ML | SIN02864P | SYRUP | 4 mg/5 ml | 5/22/1989 | |
| BROMHEXINE TABLET 8 mg | SIN02479P | TABLET | 8 mg | 3/6/1989 | |
| AXCEL BROMHEXINE TABLET 8 mg | SIN10906P | TABLET | 8 mg | 4/30/1999 | |
| MUCOLIX ELIXIR 4 mg/5 ml | SIN02846P | ELIXIR | 4 mg/5 ml | 5/22/1989 | |
| BISLAN TABLET 8 mg | SIN10582P | TABLET | 8 mg | 12/22/1998 | |
| BROMHEXINE ELIXIR 4 mg/5 ml | SIN02468P | ELIXIR | 4 mg/5 ml | 2/27/1989 | |
| HOSOLVON TABLET 8 mg | SIN05034P | TABLET | 8.00mg | 8/30/1990 | |
| DURO-TUSS CHESTY COUGH LIQUID | SIN10014P | SOLUTION | 12 mg/15 ml | 9/21/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bromhexine Hydrochloride Injection | 国药准字H20213214 | 化学药品 | 注射剂 | 3/23/2021 | |
| Bromhexine Hydrochloride Injection | 国药准字H20223868 | 化学药品 | 注射剂 | 11/22/2022 | |
| Bromhexine Hydrochloride Injection | 国药准字H11022093 | 化学药品 | 注射剂(小容量注射剂) | 11/2/2020 | |
| Bromhexine Hydrochloride Injection | 国药准字H20233628 | 化学药品 | 注射剂 | 5/29/2023 | |
| Bromhexine Hydrochloride Injection | 国药准字H20234640 | 化学药品 | 注射剂 | 12/13/2023 | |
| Bromhexine Hydrochloride Injection | 国药准字H20243551 | 化学药品 | 注射剂 | 4/24/2024 | |
| Bromhexine Hydrochloride Injection | 国药准字H20234075 | 化学药品 | 注射剂 | 8/29/2023 | |
| Bromhexine Hydrochloride Injection | 国药准字H20244392 | 化学药品 | 注射剂 | 7/9/2024 | |
| Bromhexine Hydrochloride Injection | 国药准字H20223720 | 化学药品 | 注射剂 | 11/23/2022 | |
| Bromhexine Hydrochloride Injection | 国药准字H20244991 | 化学药品 | 注射剂 | 9/26/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NEODINE TAB | N/A | N/A | N/A | 1/11/2002 | |
| FAST FLU TAB | N/A | N/A | N/A | 10/18/2002 | |
| X-COLD CAP | N/A | N/A | N/A | 6/30/2000 | |
| SPEEDY COLD AND COUGH CAP | N/A | N/A | N/A | 9/11/2006 | |
| SURE-RELIEF COLD AND COUGH CAP | N/A | N/A | N/A | 6/30/2000 | |
| ANTI-COLD TAB | N/A | N/A | N/A | 9/30/2002 | |
| COFENZA CAP | N/A | N/A | N/A | 6/30/2000 | |
| Q-COLD TAB | N/A | N/A | N/A | 9/30/2002 | |
| BISOPIN TAB 8MG | N/A | N/A | N/A | 1/6/1992 | |
| N2012 CAP | N/A | karen laboratories o/b karen pharmaceutical co ltd | N/A | N/A | 2/8/2010 |
TGA Drug Approvals
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