Last reviewed 2026-05-21 · How we verify

Epiferol (REPROTEROL)

Phase 2 active Small molecule Under review Quality 0/100

Epiferol (generic name: REPROTEROL) is a reproterol drug. It is currently in Phase 2 development for Asthma.

Epiferol works by stimulating the beta-2 adrenergic receptor to increase the concentration of cyclic AMP, leading to bronchodilation.

Epiferol is a small molecule that acts as a beta-2 adrenergic receptor agonist. It is being studied in combination with disodium cromoglycate for the treatment of exercise-induced asthma.

Likelihood of approval

15.3% 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).

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	REPROTEROL
Drug class	reproterol
Target	Beta-2 adrenergic receptor
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Imagine your airways are like a narrow road that gets congested when you have asthma. Epiferol helps to relax the muscles around the road, making it wider and easier to breathe. This is because it stimulates the beta-2 adrenergic receptor, which sends a signal to the muscles to relax and open up the airway.

Approved indications

Asthma

Common side effects

No common side effects on file.

Key clinical trials

To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol (PHASE2)

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:

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

Frequently asked questions about Epiferol

What is Epiferol?

Epiferol (REPROTEROL) is a reproterol drug, indicated for Asthma.

How does Epiferol work?

Epiferol works by stimulating the beta-2 adrenergic receptor to increase the concentration of cyclic AMP, leading to bronchodilation.

What is Epiferol used for?

Epiferol is indicated for Asthma.

What is the generic name of Epiferol?

REPROTEROL is the generic (nonproprietary) name of Epiferol.

What drug class is Epiferol in?

Epiferol belongs to the reproterol class. See all reproterol drugs at /class/reproterol.

What development phase is Epiferol in?

Epiferol is in Phase 2.

What does Epiferol target?

Epiferol targets Beta-2 adrenergic receptor and is a reproterol.

Drug class: All reproterol drugs
Target: All drugs targeting Beta-2 adrenergic receptor
Therapeutic area: All drugs in Respiratory
Indication: Drugs for Asthma

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