Drug Type Small molecule drug |
Synonyms Ambroxol, Ambroxol Hydrochlorcide, Ambroxol hydrochloride (JAN) + [69] |
Target |
Action modulators |
Mechanism SCNA modulators(Sodium voltage-gated channel alpha subunits modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (27 May 1983), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC13H19Br2ClN2O |
InChIKeyQNVKOSLOVOTXKF-PFWPSKEQSA-N |
CAS Registry23828-92-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D01479 | Ambroxol Hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Chronic sinusitis | Japan | 03 Mar 1993 | |
Sputum excretion difficulty | Japan | 29 Nov 1991 | |
Acute Bronchitis | Japan | 13 Feb 1986 | |
Asthma | Japan | 13 Feb 1986 | |
Bronchiectasis | Japan | 27 May 1983 | |
Bronchitis, Chronic | Japan | 27 May 1983 | |
Pneumoconiosis | Japan | 27 May 1983 | |
Pulmonary Tuberculosis | Japan | 27 May 1983 | |
Respiratory Distress Syndrome, Newborn | China | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Respiratory Diseases | NDA/BLA | China | 10 May 2022 | |
Respiratory Diseases | NDA/BLA | China | 10 May 2022 | |
Parkinson Disease | Phase 3 | United Kingdom | 25 Feb 2025 | |
Acute respiratory disease | Phase 3 | China | 01 Sep 2022 | |
Acute respiratory disease | Phase 3 | China | 01 Sep 2022 | |
Chronic disease of respiratory system | Phase 3 | China | 01 Sep 2022 | |
Chronic disease of respiratory system | Phase 3 | China | 01 Sep 2022 | |
Pneumonia | Phase 3 | China | 01 Sep 2022 | |
Pneumonia | Phase 3 | China | 01 Sep 2022 | |
Bronchopulmonary disease | Phase 3 | China | 26 Jul 2018 |
Phase 2 | Progressive Supranuclear Palsy Atypical beta-Glucocerebrosidase (GCase; GBA) | - | ljdeuupond(ozmnakfmto) = xnyulppybf wcokemekjn (okksmhvgzv, 4.8) | Positive | 27 Aug 2023 | ||
Placebo | ljdeuupond(ozmnakfmto) = vzrplabiwp wcokemekjn (okksmhvgzv, 2.5) | ||||||
Not Applicable | - | 4,025 | dwugovrkhp(auufqwzrdw) = pzcmdkgcuc ywlzociorv (dyvnjhmnta ) View more | - | 20 Oct 2022 | ||
dwugovrkhp(auufqwzrdw) = ajkrotwvrd ywlzociorv (dyvnjhmnta ) View more | |||||||
Phase 2 | 24 | (Patients with Parkinson Disease with GBA1 mutations) | ezwxfwtjna(zehdmmciwt) = uuunuejjew cgkntpvplp (gdkmzicwtb, 40) View more | - | 01 Apr 2020 | ||
(Patients with Parkinson Disease without GBA1 mutations) | ezwxfwtjna(zehdmmciwt) = ojoplspvpo cgkntpvplp (gdkmzicwtb, 40) View more | ||||||
Phase 3 | 390 | Ambroxol Hard-Boiled Lozenges | orpvaekphe(qrwofrsfsn) = birxwtcdis ewrqivcafv (bxzhsawxaf, 0.259) View more | Negative | 01 Dec 2019 | ||
Placebo | orpvaekphe(qrwofrsfsn) = dnqkhqahbd ewrqivcafv (bxzhsawxaf, 0.243) View more | ||||||
Phase 3 | 249 | (Ambroxol Lozenges 20 mg) | cohminqqnp(utjvearmuo) = zpiqiofpif mdqsolcoli (fpmuioviem, 0.020) View more | - | 11 Jul 2019 | ||
Placebo+Ambroxol (Placebo) | cohminqqnp(utjvearmuo) = cckqkamism mdqsolcoli (fpmuioviem, 0.020) View more | ||||||
Phase 1 | - | - | (Mucosolvan ® Adult Syrup) | vsylgawuem(bipuvptsms) = hqzfgrgnuh fsakkxvjee (lfkssibcnr, 30.38) View more | - | 31 Dec 2015 | |
(Ambroxol Hydrochloride Soft Pastille) | vsylgawuem(bipuvptsms) = pgafbtlrck fsakkxvjee (lfkssibcnr, 28.62) View more | ||||||
Phase 1 | - | 24 | (Lasolvan 75mg) | fqraljkubv(glyatmiscj) = wpjhqujava msezhyzpcq (bqlzkdnrdd, 28.859) View more | - | 13 May 2015 | |
(Lasolvan 60mg) | fqraljkubv(glyatmiscj) = ncbdlpnbvc msezhyzpcq (bqlzkdnrdd, 28.292) View more |