MedPath

Ambroxol

Generic Name
Ambroxol
Drug Type
Small Molecule
Chemical Formula
C13H18Br2N2O
CAS Number
18683-91-5
Unique Ingredient Identifier
200168S0CL
Background

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 Therapies
Airway secretion clearance therapy

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

First Posted Date
2024-09-26
Last Posted Date
2024-09-26
Lead Sponsor
Ozlem Goker-Alpan
Target Recruit Count
10
Registration Number
NCT06614894
Locations
🇺🇸

Lysosomal & Rare Disorders Research & Treatment Center, Inc., Fairfax, Virginia, United States

High-Dose Ambroxol in GBA1-Related Parkinson

Phase 1
Recruiting
Conditions
Parkinson Disease
GBA Gene Mutation
Interventions
First Posted Date
2024-01-05
Last Posted Date
2024-02-08
Lead Sponsor
Agyany Pharma LTD
Target Recruit Count
40
Registration Number
NCT06193421
Locations
🇮🇱

Shaare Zedek Medical Center, Jerusalem, Israel

A Double-blind Randomised, Placebo-controlled Clinical Trial to Test Ambroxol Treatment in ALS

Phase 2
Recruiting
Conditions
Amyotrophic Lateral Sclerosis
Interventions
Drug: Placebo
First Posted Date
2023-07-25
Last Posted Date
2023-09-07
Lead Sponsor
The Florey Institute of Neuroscience and Mental Health
Target Recruit Count
50
Registration Number
NCT05959850
Locations
🇦🇺

Concord Repatriation General Hospital, Sydney, New South Wales, Australia

🇦🇺

Launceston General Hospital, Launceston, Tasmania, Australia

🇦🇺

Brain and Mind Centre, Sydney, New South Wales, Australia

and more 2 locations

GRoningen Early-PD Ambroxol Treatment

Phase 2
Recruiting
Conditions
Parkinson
Parkinson Disease
Interventions
First Posted Date
2023-04-26
Last Posted Date
2023-05-10
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
80
Registration Number
NCT05830396
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

Ambroxol to Slow Progression in Parkinson Disease

Phase 3
Recruiting
Conditions
Parkinson Disease
Interventions
First Posted Date
2023-03-21
Last Posted Date
2025-05-01
Lead Sponsor
University College, London
Target Recruit Count
330
Registration Number
NCT05778617
Locations
🇬🇧

University Hospitals Birmingham, Birmingham, United Kingdom

🇬🇧

Southmead Hospital Bristol, Bristol, United Kingdom

🇬🇧

Addenbrookes NHS Trust, Cambridge, United Kingdom

and more 12 locations

Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients

Phase 4
Completed
Conditions
Severe Pneumonia
Community-acquired Pneumonia
Hospital-acquired Pneumonia
Critical Illness
Interventions
Other: Standard Therapy
First Posted Date
2022-12-23
Last Posted Date
2023-12-27
Lead Sponsor
National University of Malaysia
Target Recruit Count
32
Registration Number
NCT05663905
Locations
🇲🇾

Hospital Canselor Tuanku Muhriz UKM (HCTM), Cheras, Kuala Lumpur, Malaysia

Effect of Ambroxol in Diabetic Peripheral Neuropathy

Not Applicable
Not yet recruiting
Conditions
Diabetic Neuropathy Peripheral
Interventions
First Posted Date
2022-09-28
Last Posted Date
2022-09-29
Lead Sponsor
Ain Shams University
Target Recruit Count
80
Registration Number
NCT05558878
Locations
🇪🇬

Ain Shams university Hospital, Cairo, Egypt

Ambroxol as a Disease-modifying Treatment in GBA-PD

Phase 2
Active, not recruiting
Conditions
Parkinson Disease
GBA Gene Mutation
Interventions
First Posted Date
2022-03-18
Last Posted Date
2023-09-11
Lead Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Target Recruit Count
65
Registration Number
NCT05287503
Locations
🇮🇹

University of Campania "Luigi Vanvitelli", Naples, Italy

🇮🇹

IRCCS National Neurological Institute "C. Mondino" Foundation, Pavia, Italy

🇮🇹

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy

A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia

Conditions
Community-acquired Pneumonia
Interventions
Drug: Other oral mucolytic drugs
Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule
First Posted Date
2021-08-12
Last Posted Date
2021-11-26
Lead Sponsor
Beijing Grand Johamu Pharmaceutical Company, Ltd.
Target Recruit Count
10000
Registration Number
NCT05002192
Locations
🇨🇳

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

🇨🇳

Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

🇨🇳

Shanghai Pulmonary Hospital, Shanghai, Shanghai, China

and more 4 locations

Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial

Phase 2
Recruiting
Conditions
Dementia With Lewy Bodies
Interventions
Drug: Placebo
First Posted Date
2020-10-19
Last Posted Date
2023-12-21
Lead Sponsor
Helse Fonna
Target Recruit Count
180
Registration Number
NCT04588285
Locations
🇳🇴

Helse Fonna, Haugesund, Norway

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