Last reviewed 2026-06-01 · How we verify

NEPINALONE

Phase 2 active Small molecule ✓ Verified Jun 2026

NEPINALONE is a nepinalone drug. It is currently in Phase 2 development for Non-productive cough.

Nepinalone works by binding to the Sigma non-opioid intracellular receptor 1, which helps to reduce coughing.

Nepinalone is a small molecule. It has multiple synonyms, including Nepinalona and Nepinalone.

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	NEPINALONE
Drug class	nepinalone
Target	Sigma non-opioid intracellular receptor 1
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has a special switch that controls coughing. When this switch gets stuck, it can cause persistent coughing. Nepinalone is like a key that fits into this switch, helping to turn it off and stop the coughing.

Approved indications

Non-productive cough

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:

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

Frequently asked questions about NEPINALONE

What is NEPINALONE?

NEPINALONE is a nepinalone drug, indicated for Non-productive cough.

How does NEPINALONE work?

Nepinalone works by binding to the Sigma non-opioid intracellular receptor 1, which helps to reduce coughing.

What is NEPINALONE used for?

NEPINALONE is indicated for Non-productive cough.

What drug class is NEPINALONE in?

NEPINALONE belongs to the nepinalone class. See all nepinalone drugs at /class/nepinalone.

What development phase is NEPINALONE in?

NEPINALONE is in Phase 2.

What does NEPINALONE target?

NEPINALONE targets Sigma non-opioid intracellular receptor 1 and is a nepinalone.

Drug class: All nepinalone drugs
Target: All drugs targeting Sigma non-opioid intracellular receptor 1
Therapeutic area: All drugs in Pain
Indication: Drugs for Non-productive cough

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