Ambroxol Hydrochloride

Phase 3Small molecule

Boehringer Ingelheim

Ambroxol Hydrochloride is one of 48 small molecule programs targeting Parkinson disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Parkinson DiseaseRecruiting

Lewy Body DementiaNot yet recruiting

Parkinson DiseasePhase 3

Recruiting

Lewy Body DementiaPhase 2

Not yet recruiting

Competition

Competitive Landscape

92 competitors in Parkinson Disease

#DrugCompanyPhaseTrials

Brintellix

Takeda

Approved

1 2

Aricept

Eisai

Approved

1 3

Exelon

Novartis

Approved

1 4

Northera

Lundbeck

Approved

1 5

Myrbetriq

Astellas

Approved

1 6

Medrol

Pfizer

Approved

1 7

Dostinex

Keppra

Namenda

Victoza

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1/2Not yet recruiting

Lewy Body Dementia

NCT04405596

Q3 2029

Phase 3Recruiting

Parkinson Disease

NCT05778617

Clinical

Trials by Indication[1]

Treatment2 trials

GRoningen Early-PD Ambroxol Treatment

Unknown status·UUniversity Medical Center Groningen·Phase 2/3·NCT05830396·80 enrolled

Ambroxol as a Disease-modifying Treatment in GBA-PD

Completed·FFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta·Phase 2·NCT05287503·65 enrolled

Acute Cough1 trial

A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.

Completed·HHull University Teaching Hospitals NHS Trust·Phase 2·NCT03415269·14 enrolled

Parkinson1 trial

High-Dose Ambroxol in GBA1-Related Parkinson

Unknown status·AAgyany Pharma LTD·Phase 1/2·NCT06193421·40 enrolled

Pneumonia1 trial

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

Completed·NNational University of Malaysia·Phase 4·NCT05663905·32 enrolled

Parkinson disease1 trial

Ambroxol to Slow Progression in Parkinson Disease

Recruiting·UUniversity College, London·Phase 3·NCT05778617·330 enrolled

5 more indications

Lozenge1 trial

Relative Bioavailability of Ambroxol Hydrochloride Lozenge in Comparison to Ambroxol Hydrochloride Syrup (Mucosolvan®) in Healthy Female and Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02194296·20 enrolled

Respiratory Tract Diseases1 trial

A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions

Completed·ZZambon SpA·Phase 3·NCT03843541·333 enrolled

Pharyngitis1 trial

Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00148499·751 enrolled

Oral1 trial

Effects of Oral Mucolytics on Tear Film and Ocular Surface

Completed·HHallym University Kangnam Sacred Heart Hospital·Phase 1/2·NCT01713179·20 enrolled

Lewy body dementia1 trial

Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

Not yet recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 1/2·NCT04405596·15 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Ambroxol Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ambroxol Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ambroxol Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Boehringer Ingelheim

Ambroxol Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2029

Trials by Indication[1]

Treatment2 trials

Acute Cough1 trial

Parkinson1 trial

Pneumonia1 trial

Parkinson disease1 trial

Lozenge1 trial

Respiratory Tract Diseases1 trial

Pharyngitis1 trial

Oral1 trial

Lewy body dementia1 trial

References

Drug Info

Quick Facts

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