Last reviewed 2026-06-03 · How we verify

NAC + Bromhexine (BMX)

Universidade Federal do Ceara · Phase 3 active Small molecule Under review

NAC + Bromhexine (BMX) is a Mucolytic/secretolytic combination Small molecule drug developed by Universidade Federal do Ceara. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion, Acute respiratory infections with excessive mucus production, Bronchiectasis.

NAC and bromhexine work synergistically to reduce mucus viscosity and promote clearance while providing antioxidant and anti-inflammatory effects.

NAC + Bromhexine (BMX) is being studied as a potential treatment for COVID-19 in a clinical trial. The mechanism of action of Bromhexine is currently unknown, but it is classified as a small molecule.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	NAC + Bromhexine (BMX)
Sponsor	Universidade Federal do Ceara
Drug class	Mucolytic/secretolytic combination
Modality	Small molecule
Therapeutic area	Respiratory/Pulmonology
Phase	Phase 3

Mechanism of action

N-acetylcysteine (NAC) is a mucolytic agent that breaks disulfide bonds in mucoproteins, reducing sputum viscosity and facilitating expectoration, while also providing antioxidant protection. Bromhexine is a secretolytic agent that increases mucus production and ciliary activity to enhance mucociliary clearance. Together, they improve airway clearance and reduce inflammation in respiratory conditions.

Approved indications

Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion
Acute respiratory infections with excessive mucus production
Bronchiectasis

Common side effects

Gastrointestinal upset (nausea, dyspepsia)
Headache
Rash or allergic reactions
Dizziness

Key clinical trials

Clinical Trial With N-acetylcysteine and Bromhexine for COVID-19 (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

NAC + Bromhexine (BMX) CI brief — competitive landscape report
NAC + Bromhexine (BMX) updates RSS · CI watch RSS
Universidade Federal do Ceara portfolio CI

Frequently asked questions about NAC + Bromhexine (BMX)

What is NAC + Bromhexine (BMX)?

NAC + Bromhexine (BMX) is a Mucolytic/secretolytic combination drug developed by Universidade Federal do Ceara, indicated for Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion, Acute respiratory infections with excessive mucus production, Bronchiectasis.

How does NAC + Bromhexine (BMX) work?

NAC and bromhexine work synergistically to reduce mucus viscosity and promote clearance while providing antioxidant and anti-inflammatory effects.

What is NAC + Bromhexine (BMX) used for?

NAC + Bromhexine (BMX) is indicated for Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion, Acute respiratory infections with excessive mucus production, Bronchiectasis.

Who makes NAC + Bromhexine (BMX)?

NAC + Bromhexine (BMX) is developed by Universidade Federal do Ceara (see full Universidade Federal do Ceara pipeline at /company/universidade-federal-do-ceara).

What drug class is NAC + Bromhexine (BMX) in?

NAC + Bromhexine (BMX) belongs to the Mucolytic/secretolytic combination class. See all Mucolytic/secretolytic combination drugs at /class/mucolytic-secretolytic-combination.

What development phase is NAC + Bromhexine (BMX) in?

NAC + Bromhexine (BMX) is in Phase 3.

What are the side effects of NAC + Bromhexine (BMX)?

Common side effects of NAC + Bromhexine (BMX) include Gastrointestinal upset (nausea, dyspepsia), Headache, Rash or allergic reactions, Dizziness.

Drug class: All Mucolytic/secretolytic combination drugs
Manufacturer: Universidade Federal do Ceara — full pipeline
Therapeutic area: All drugs in Respiratory/Pulmonology
Indication: Drugs for Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion
Indication: Drugs for Acute respiratory infections with excessive mucus production
Indication: Drugs for Bronchiectasis

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