Last reviewed 2026-04-20 · How we verify

Lyopect (NICOCODINE)

Phase 2 active Small molecule

Lyopect (generic name: NICOCODINE) is a nicocodine drug. It is currently in Phase 2 development.

Lyopect works by binding to opioid receptors in the brain, altering the perception of pain.

Lyopect (NICOCODINE) is a small molecule drug in the nicocodine class, but specific details about its development, commercial status, and approved indications are not available. As a nicocodine, it is likely a centrally acting opioid analgesic, but its exact mechanism and target are unknown. Further research is needed to understand its pharmacological properties and clinical applications. Lyopect's commercial status, including patent status and generic availability, is also unclear. As a result, its safety profile and potential side effects are not well established.

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	NICOCODINE
Drug class	nicocodine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your brain has special locks that control how you feel pain. Lyopect is a key that fits into these locks, changing the way pain signals are sent and received. This can help reduce the sensation of pain, but it can also have other effects on the body.

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:

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

Frequently asked questions about Lyopect

What is Lyopect?

Lyopect (NICOCODINE) is a nicocodine drug.

How does Lyopect work?

Lyopect works by binding to opioid receptors in the brain, altering the perception of pain.

What is the generic name of Lyopect?

NICOCODINE is the generic (nonproprietary) name of Lyopect.

What drug class is Lyopect in?

Lyopect belongs to the nicocodine class. See all nicocodine drugs at /class/nicocodine.

What development phase is Lyopect in?

Lyopect is in Phase 2.

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

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