Drugs / Ambroxol
Ambroxol
also known as
Ambroxol Hydrochloride · Mucosolvan · ABX · Ambroxol HCl · BIH1526 · Lasolvan · Mucoangin? · Mucopect · +1 more
Small molecule targets GBA1 via activation
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 met primary | ||||||
| Phase 1 | NCT02036775 | Mar → May 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01573663 | Feb → Apr 2012 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT02572609 | Nov → Dec 2011 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 1 | NCT02194283 | Oct → Nov 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02194257 | Oct → Dec 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02194270 | Sep 2004 → Feb 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04405596 | Jan 2025 → Jan 2026 overdue | Lewy body dementia | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06193421 | Oct 2023 → Feb 2025 | Parkinson disease | Agyany Pharma LTD | Unknown | No outcome recorded |
| Phase 1/2 | NCT01463215 | Dec 2012 → Dec 2014 | Gaucher disease type I | Exsar Corporation | Suspended | No outcome recorded |
| Phase 1/2 | NCT01713179 | Aug → Oct 2011 | — | Hallym University Kangnam Sacred Heart Hospital | Completed | No outcome recorded |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT05959850 | Jun 2023 → Jun 2024 | amyotrophic lateral sclerosis | The Florey Institute of Neuroscience and Mental Health | Unknown | No outcome recorded |
| Phase 2 | NCT05287503 | Mar 2022 → Dec 2024 | Parkinson disease | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Completed | No outcome recorded |
| Phase 2 | NCT04588285 | May 2021 → Sep 2027 expected | Lewy body dementia | Helse Fonna | Recruiting | No outcome recorded |
| Phase 2 | NCT03950050 | Mar 2019 → Nov 2022 | Gaucher disease type I | Shaare Zedek Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03415269 | Feb → Apr 2018 | — | Hull University Teaching Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT02941822 | Dec 2016 → Apr 2018 | Parkinson disease | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02914366 | Nov 2015 → Dec 2025 | Parkinson disease | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | Missed primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06614894 | Dec 2024 → May 2026 overdue | mucopolysaccharidosis type 3 | Ozlem Goker-Alpan | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05830396 | May 2023 → Jul 2025 | Parkinson disease | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT00525044 | Aug 2007 → Jan 2008 | acute pharyngitis | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00148499 | Oct 2005 → Jun 2006 | acute pharyngitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00144274 | Apr → Nov 2005 | pharyngitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05663905 | Jan → Oct 2023 | pneumonia | National University of Malaysia | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07285369 | Mar 2025 → Mar 2026 | Gaucher disease type III | Agyany Pharma LTD | Terminated | No outcome recorded |
| — | NCT05558878 | Oct 2022 → Oct 2023 | diabetic polyneuropathy | Ain Shams University | Unknown | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT02194296 Comparator | Jun → Jul 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01361802 Comparator | May → Aug 2011 | acute pharyngitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT05778617 Comparator | Feb 2025 → Feb 2029 expected | Parkinson disease | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT03843541 Comparator | Jun 2019 → Jan 2021 | mucus inspissation of respiratory tract, respiratory system disorder | Zambon SpA | Completed | Met primary |
| Phase 3 | NCT03583658 Comparator | Jun → Sep 2018 | pharyngitis | Sanofi | Completed | No outcome recorded |
| — | NCT03177889 Background | Dec 2021 → Aug 2023 | bronchiectasis | Guangzhou Institute of Respiratory Disease | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-08-21 | Opella Healthcare Group SAS, a Sanofi Company | Regulatory Reativação do medicamento Mucosolvan Xarope Adulto 6mg/ml (120 ml). opella.com ↗
A Opella informa que, em 21/08/2026, protocolou junto à Agência Nacional de Vigilância Sanitária (ANVISA) a notificação de reativação da fabricação dos medicamentos MUCOSOLVAN XAROPE ADULTO 6MG/ML (120 ML). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-21 | Opella Healthcare Group SAS, a Sanofi Company | Reativação do medicamento Mucosolvan Xarope Adulto 6mg/ml (120 ml). opella.com ↗ |
| 2026-06-30 | Opella Healthcare Group SAS, a Sanofi Company | Desabastecimento temporário do medicamento Mucosolvan Xarope adulto 6MG/ML 120 ML. opella.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ambroxol | “oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid]” NCT03177889 ↗31“Twenty-four participants received ambroxol (male n = 13, 54.2%; mean ± standard deviation [SD] age 25.0 ± 6.4 years)” PMID 32372294 ↗ May 2020 “Ambroxol” NCT06614894 ↗ |
| Known as | ABX | “the chaperone ambroxol (ABX) increases GCase levels and modulates α-synuclein levels in the blood and cerebrospinal fluid (CSF).” PMID 38027469 ↗ Nov 2023 |
| Known as | Ambroxol HCl | “Ambroxol HCl 30mg, PO, single dose” NCT01573663 ↗ |
| Known as | Ambroxol Hydrochloride | “Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.” NCT03843541 ↗8“20 mg Ambroxol Hydrochloride Lozenge in Comparison to 30 mg Ambroxol Hydrochloride Syrup (Mucosolvan®)” NCT02194296 ↗ “Ambroxol hydrochloride was administered orally to the ambroxol group.” PMID 23538621 ↗ Jul 2013 “Ambroxol Hydrochloride 30 mg oral pill/tablet - 9 mg/kg/day” NCT06614894 ↗ “Drug Ambroxol hydrochloride 200 mg plus excipients.” NCT05287503 ↗ “Ambroxol hydrochloride - soft pastille” NCT02194270 ↗ “Ambroxol hydrochloride (BIH1526)” NCT03583658 ↗ “Drug: Ambroxol Hydrochloride” NCT06193421 ↗ “Drug: Ambroxol Hydrochloride” NCT03415269 ↗ |
| Known as | BIH1526 | “Drug: ambroxol BIH1526” NCT03583658 ↗ |
| Known as | Lasolvan | “Two New Oral Formulations of Ambroxol Hydrochloride as Lasolvan® Prolonged-release Hard Capsules 75 mg and Lasolvan® Effervescent Tablets 60 mg Compared to Lasolvan® Tablets 30 mg.” NCT02036775 ↗ |
| Known as | Mucoangin? | “lozenges containing 20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and lozenges containing 3 mg benzocaine” NCT00148499 ↗ |
| Known as | Mucopect | “Ambroxol hydrochloride (Mucopect®, trans-4\[2-amino-3.5-dibrombenzylamino\]-cyclohexanhydro-chloride, 60 mg, Boehringer Ingelheim) was administered orally to subjects in the...” NCT01713179 ↗ |
| Known as | Mucosolvan | “compared to ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.” NCT02572609 ↗2“20 mg Ambroxol Hydrochloride Lozenge in Comparison to 30 mg Ambroxol Hydrochloride Syrup (Mucosolvan®)” NCT02194296 ↗ “Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan(®) Retard) Compared” PMID 32372294 ↗ May 2020 |
| Known as | Tabcin | ChEMBL registry synonym — accepted as the source's own label CHEMBL153479 ↗ |
| Action | Activate | “ambroxol increases β-glucocerebrosidase (GCase) enzyme activity” PMID 31930374 ↗ Apr 2020 |
| Modality | Small molecule | “Ambroxol, has a small molecule chaperone, has been shown in healthy nonhuman primates to cross the blood-brain barrier” NCT03950050 ↗ |
| Route | Oral | “given once daily by mouth” NCT01463215 ↗ |
| Target | GBA1 | “Glucocerebrosidase (GCase) is a lysosomal enzyme encoded by the GBA1 beta-glucosylceramidase gene (GBA). Heterozygous GBA mutations are recognized as the most frequent genetic...” NCT05287503 ↗ |