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ambroxol BIH1526 — Competitive Intelligence Brief

ambroxol BIH1526 (ambroxol BIH1526) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Mucolytic agent. Area: Respiratory.

phase 3 Mucolytic agent Respiratory Small molecule Live · refreshed every 30 min

Target snapshot

ambroxol BIH1526 (ambroxol BIH1526) — Sanofi. Ambroxol BIH1526 is a mucolytic agent that works by increasing the concentration of glutathione in the airways, which helps to break down and clear mucus.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
ambroxol BIH1526 TARGET ambroxol BIH1526 Sanofi phase 3 Mucolytic agent
N-acetylcysteine N-acetylcysteine University of Turin, Italy marketed Antioxidant, mucolytic agent Glutathione synthesis pathway; reactive oxygen species
Hypertonic saline and epinephrine Hypertonic saline and epinephrine Le Bonheur Children's Hospital marketed Combination bronchodilator and mucolytic agent Alpha-1 adrenergic receptors, beta-2 adrenergic receptors, osmotic gradient modulation
N-acetylcystein N-acetylcystein Assistance Publique - Hôpitaux de Paris marketed Antioxidant; mucolytic agent Glutathione synthesis pathway; free radicals; mucus proteins
Acetylcysteine (NAC) Acetylcysteine (NAC) Clinica Universidad de Navarra, Universidad de Navarra marketed Mucolytic agent; antioxidant Glutathione synthesis; disulfide bonds in mucoproteins
Mucolox® alone Mucolox® alone University of Alberta marketed Mucolytic agent
Ambroxol Hydrochloride Ambroxol Hydrochloride National University of Malaysia marketed Mucolytic agent

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Mucolytic agent class)

  1. GlaxoSmithKline · 1 drug in this class
  2. National University of Malaysia · 1 drug in this class
  3. Sanofi · 1 drug in this class
  4. University College, London · 1 drug in this class
  5. University of Alberta · 1 drug in this class

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Cite this brief

Drug Landscape (2026). ambroxol BIH1526 — Competitive Intelligence Brief. https://druglandscape.com/ci/ambroxol-bih1526. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing