Last reviewed 2026-06-01 · How we verify

Nisintil (ALPHAPRODINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Nisintil (generic name: ALPHAPRODINE) is a alphaprodine drug. It is currently in Phase 2 development.

Nisintil works by binding to opioid receptors in the brain, altering the perception of and response to pain.

Nisintil is a small molecule with the synonyms ALPHAPRODINE HCL, ALPHAPRODINE HYDROCHLORIDE, and ALPHAPRODINE HYDROCHLORIDE CII. It is also known as NU 1196.

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	ALPHAPRODINE
Drug class	alphaprodine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your brain has special locks for pain signals. Nisintil is a key that fits into these locks, reducing the pain signal and making you feel better. This is similar to how other opioid medications work, but nisintil's exact mechanism is not fully understood.

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:

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

Frequently asked questions about Nisintil

What is Nisintil?

Nisintil (ALPHAPRODINE) is a alphaprodine drug.

How does Nisintil work?

Nisintil works by binding to opioid receptors in the brain, altering the perception of and response to pain.

What is the generic name of Nisintil?

ALPHAPRODINE is the generic (nonproprietary) name of Nisintil.

What drug class is Nisintil in?

Nisintil belongs to the alphaprodine class. See all alphaprodine drugs at /class/alphaprodine.

What development phase is Nisintil in?

Nisintil is in Phase 2.

Drug class: All alphaprodine drugs
Therapeutic area: All drugs in Pain

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