Last reviewed 2026-05-28 · How we verify

Nirvanil (VALNOCTAMIDE)

Phase 3 active Small molecule ✓ Verified May 2026 Quality 24/100

Nirvanil (generic name: VALNOCTAMIDE) is a valnoctamide drug. It is currently in Phase 3 development.

Nirvanil works by interacting with the body's nervous system to produce a sedative effect.

Nirvanil is a small molecule. It is also known by the synonyms AXIQUEL, MCN-X-181, NSC-32363, NSC-34092, VALNOCTAMIDA, and VALNOCTAMIDE.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	VALNOCTAMIDE
Drug class	valnoctamide
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 3

Mechanism of action

Imagine your nervous system as a busy highway with many cars (neurotransmitters) constantly moving. Nirvanil is like a traffic cop that helps slow down the traffic, making it easier for you to relax and fall asleep. This is a simplified explanation of how Nirvanil works, but the actual mechanism is more complex and not fully understood.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Valnoctamide in Mania (PHASE3)

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:

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

Frequently asked questions about Nirvanil

What is Nirvanil?

Nirvanil (VALNOCTAMIDE) is a valnoctamide drug.

How does Nirvanil work?

Nirvanil works by interacting with the body's nervous system to produce a sedative effect.

What is the generic name of Nirvanil?

VALNOCTAMIDE is the generic (nonproprietary) name of Nirvanil.

What drug class is Nirvanil in?

Nirvanil belongs to the valnoctamide class. See all valnoctamide drugs at /class/valnoctamide.

What development phase is Nirvanil in?

Nirvanil is in Phase 3.

Drug class: All valnoctamide drugs
Therapeutic area: All drugs in Neuroscience

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