Last reviewed 2026-05-22 · How we verify

Sedapain (EPTAZOCINE)

Phase 2 active Small molecule ✓ Verified May 2026

Sedapain (generic name: EPTAZOCINE) is a eptazocine drug. It is currently in Phase 2 development.

Eptazocine is a kappa opioid receptor agonist, which means it binds to and activates a specific type of opioid receptor in the brain.

Sedapain (Eptazocine) is a small molecule drug in the eptazocine class, but its target and exact mechanism of action are unknown. It is not clear if it has been approved by the FDA or if it is commercially available. As more information is not available, it is difficult to provide a comprehensive summary. Further research is needed to understand its approved indications, pharmacokinetic properties, and safety considerations. Its commercial status, including patent status and generic availability, is also unclear.

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	EPTAZOCINE
Drug class	eptazocine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your brain has many locks, and each lock has a specific key that fits perfectly. Eptazocine is like a key that fits into a specific lock, called the kappa opioid receptor, which helps to reduce pain signals sent to the brain.

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:

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

Frequently asked questions about Sedapain

What is Sedapain?

Sedapain (EPTAZOCINE) is a eptazocine drug.

How does Sedapain work?

Eptazocine is a kappa opioid receptor agonist, which means it binds to and activates a specific type of opioid receptor in the brain.

What is the generic name of Sedapain?

EPTAZOCINE is the generic (nonproprietary) name of Sedapain.

What drug class is Sedapain in?

Sedapain belongs to the eptazocine class. See all eptazocine drugs at /class/eptazocine.

What development phase is Sedapain in?

Sedapain is in Phase 2.

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

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