Ambroxol

Overview

Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. It is the active ingredient of Mucosolvan, Lasolvan or Mucoangin. The substance is a mucoactive drug with several properties including secretolytic and secretomotoric actions that restore the physiological clearance mechanisms of the respiratory tract which play an important role in the body’s natural defence mechanisms. It stimulates synthesis and release of surfactant by type II pneumocytes. Surfactants acts as an anti-glue factor by reducing the adhesion of mucus to the bronchial wall, in improving its transport and in providing protection against infection and irritating agents.

Indication

Ambroxol is indicated for secretolytic therapy in bronchoplmonary disease with abnormal mucus secretion and transport. It allows the mucus to be more easily cleared and ease a patient's breathing.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Open Label Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacologic Properties of High Dose Ambroxol Hydrochloride in Adult (≥ 18 Years of Age) Subjects With MPS III	2024/09/26	NCT06614894	Phase 2	Not yet recruiting	Ozlem Goker-Alpan
High-Dose Ambroxol in GBA1-Related Parkinson	2024/01/05	NCT06193421	Phase 1	Recruiting	Agyany Pharma LTD
A Double-blind Randomised, Placebo-controlled Clinical Trial to Test Ambroxol Treatment in ALS	2023/07/25	NCT05959850	Phase 2	Recruiting	The Florey Institute of Neuroscience and Mental Health
GRoningen Early-PD Ambroxol Treatment	2023/04/26	NCT05830396	Phase 2	Recruiting	University Medical Center Groningen
Ambroxol to Slow Progression in Parkinson Disease	2023/03/21	NCT05778617	Phase 3	Recruiting	University College, London
Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients	2022/12/23	NCT05663905	Phase 4	Completed	National University of Malaysia
Effect of Ambroxol in Diabetic Peripheral Neuropathy	2022/09/28	NCT05558878	Not Applicable	Not yet recruiting	Ain Shams University
Ambroxol as a Disease-modifying Treatment in GBA-PD	2022/03/18	NCT05287503	Phase 2	Active, not recruiting	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia	2021/08/12	NCT05002192	N/A	UNKNOWN	Beijing Grand Johamu Pharmaceutical Company, Ltd.
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial	2020/10/19	NCT04588285	Phase 2	Recruiting	Helse Fonna

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
MUCOCLEAR SYRUP 30 mg/5 ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN10547P	SYRUP	30 mg/5 ml	12/12/1998
MUCOCLEAR TABLET 30 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN10548P	TABLET	30 mg	12/12/1998
SHINOXOL TABLETS 30 mg	Y S P INDUSTRIES (M) SDN BHD	SIN07180P	TABLET	30 mg	10/9/1992
Mucosolvan 24 Hours Capsule 75mg	Sanofi Winthrop Industrie	SIN13373P	CAPSULE, DELAYED RELEASE	75mg	11/15/2007
POLIBROXOL TABLET 30 mg	POLIPHARM CO LTD	SIN09305P	TABLET	30 mg	4/16/1997
MUCOSOLVAN LIQUID 30 mg/5 ml	Delpharm Reims	SIN03515P	ELIXIR	30mg/5ml	6/30/1989
AMXOL TABLETS 30 mg	BIOLAB CO LTD	SIN02983P	TABLET	30 mg	5/20/1989
STREPSILS CHESTY COUGH LOZENGE	RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD	SIN11716P	LOZENGE	15 mg	11/15/2001
AXOL LIQUID 3 mg/ml	Y S P INDUSTRIES (M) SDN BHD	SIN08999P	SOLUTION	3 mg/ml	11/7/1996
MUCOSOLVAN TABLET 30 mg	Delpharm Reims	SIN02696P	TABLET	30 mg	5/2/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Ambroxol Hydrochloride and Sodium Chloride Injection	安徽双鹤药业有限责任公司	国药准字H20193429	化学药品	注射剂	12/30/2019
Ambroxol Hydrochloride and Sodium Chloride Injection	四川科伦药业股份有限公司	国药准字H20183521	化学药品	注射剂	8/23/2023
Ambroxol Hydrochloride and Sodium Chloride Injection	江苏豪森药业集团有限公司	国药准字H20031120	化学药品	注射剂	6/30/2020
Ambroxol Hydrochloride and Sodium Chloride Injection	山东齐都药业有限公司	国药准字H20193090	化学药品	注射剂	2/23/2024
Ambroxol Hydrochloride and Sodium Chloride Injection	石家庄四药有限公司	国药准字H20163191	化学药品	注射剂	3/16/2021
Ambroxol Hydrochloride and Sodium Chloride Injection	山东鲁抗辰欣药业有限公司	国药准字H20183176	化学药品	注射剂	4/13/2023
Ambroxol Hydrochloride and Sodium Chloride Injection	山东鲁抗辰欣药业有限公司	国药准字H20183177	化学药品	注射剂	4/13/2023
Ambroxol Hydrochloride Syrup	扬子江药业集团江苏制药股份有限公司	国药准字H20083322	化学药品	糖浆剂	11/21/2022
Ambroxol Hydrochloride Syrup	天大药业（珠海）有限公司	国药准字H20058517	化学药品	糖浆剂	3/3/2020
Ambroxol Hydrochloride Syrup	南京海鲸药业股份有限公司	国药准字H20067188	化学药品	糖浆剂	3/1/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
MUCOBROX SYRUP 30MG/5ML	N/A	TRENTON-BOMA LIMITED	N/A	N/A	5/13/2010
MUBROXOL TAB 30MG	N/A	Kai Yuen Pharmaceutical Co	N/A	N/A	6/24/1999
ROISOL TAB 30MG	N/A	JULIUS CHEN & COMPANY (H.K.) LIMITED	N/A	N/A	6/22/2007
SHINOXOL TABLETS 30MG	N/A	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	N/A	N/A	9/12/2023
LANSU TABLETS 30MG	N/A	REGAL MEDICAL HEALTHCARE LIMITED	N/A	N/A	11/5/2015
TALIPIEN TABLETS 30MG	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	9/28/2017
MUCOSOLVAN TAB 30MG	N/A	SUNSTONE CHINA LIMITED	N/A	N/A	3/24/1984
LANSU ORAL SOLUTION 30MG/5ML	N/A	REGAL MEDICAL HEALTHCARE LIMITED	N/A	N/A	12/7/2015

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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