Last reviewed 2026-04-20 · How we verify

Mucothiol (DACISTEINE)

Phase 2 active Small molecule

Mucothiol (generic name: DACISTEINE) is a dacisteine drug. It is currently in Phase 2 development.

Dacisteine works by breaking down and neutralizing excess mucus in the body.

Mucothiol, also known as dacisteine, is a small molecule drug of the dacisteine class. Its original development is unclear, and its current owner is also unknown. The target of dacisteine is not specified, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to determine the potential benefits and risks of dacisteine.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	DACISTEINE
Drug class	dacisteine
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's mucus as a sticky, protective blanket that traps dust and germs. Dacisteine helps to break down this blanket, making it easier to expel and reducing the risk of infection. This can be especially helpful for people with conditions like chronic bronchitis or cystic fibrosis.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Mucothiol CI brief — competitive landscape report
Mucothiol updates RSS · CI watch RSS

Frequently asked questions about Mucothiol

What is Mucothiol?

Mucothiol (DACISTEINE) is a dacisteine drug.

How does Mucothiol work?

Dacisteine works by breaking down and neutralizing excess mucus in the body.

What is the generic name of Mucothiol?

DACISTEINE is the generic (nonproprietary) name of Mucothiol.

What drug class is Mucothiol in?

Mucothiol belongs to the dacisteine class. See all dacisteine drugs at /class/dacisteine.

What development phase is Mucothiol in?

Mucothiol is in Phase 2.

Drug class: All dacisteine drugs
Therapeutic area: All drugs in Infectious Disease

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