Last reviewed 2026-05-24 · How we verify

Acephylline (ACEFYLLINE)

Phase 2 active Small molecule ✓ Verified May 2026

Acephylline (generic name: ACEFYLLINE) is a acefylline drug. It is currently in Phase 2 development for Asthma, Bronchitis, Disorder of cardiovascular system.

Acephylline works by binding to the adenosine receptor A2b, which helps to relax airway smooth muscle and improve lung function.

Acephylline is a small molecule with an unknown mechanism of action. It is also known by various synonyms, including Dynaphylline.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	ACEFYLLINE
Drug class	acefylline
Target	Adenosine receptor A2b
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your airways are like a narrow road that gets congested when you have asthma or bronchitis. Acephylline helps to calm down the muscles that line the airways, making it easier to breathe. This is achieved by blocking the action of adenosine, a chemical that can cause these muscles to constrict.

Approved indications

Asthma
Bronchitis
Disorder of cardiovascular system

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:

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

Frequently asked questions about Acephylline

What is Acephylline?

Acephylline (ACEFYLLINE) is a acefylline drug, indicated for Asthma, Bronchitis, Disorder of cardiovascular system.

How does Acephylline work?

Acephylline works by binding to the adenosine receptor A2b, which helps to relax airway smooth muscle and improve lung function.

What is Acephylline used for?

Acephylline is indicated for Asthma, Bronchitis, Disorder of cardiovascular system.

What is the generic name of Acephylline?

ACEFYLLINE is the generic (nonproprietary) name of Acephylline.

What drug class is Acephylline in?

Acephylline belongs to the acefylline class. See all acefylline drugs at /class/acefylline.

What development phase is Acephylline in?

Acephylline is in Phase 2.

What does Acephylline target?

Acephylline targets Adenosine receptor A2b and is a acefylline.

Drug class: All acefylline drugs
Target: All drugs targeting Adenosine receptor A2b
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Asthma
Indication: Drugs for Bronchitis
Indication: Drugs for Disorder of cardiovascular system

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