Last reviewed 2026-04-20 · How we verify

Olmifon (ADRAFINIL)

Phase 2 active Small molecule Quality 19/100

Olmifon (generic name: ADRAFINIL) is a adrafinil drug. It is currently in Phase 2 development.

Olmifon works by increasing the production of neurotransmitters in the brain, such as dopamine and norepinephrine.

Olmifon, also known as Adrafinil, is a small molecule drug of the adrafinil class. It was originally developed by Louis Lafon, a French chemist, and is currently owned by a private company. The exact target of Olmifon is unknown, but it is believed to work by increasing the production of neurotransmitters such as dopamine and norepinephrine in the brain. Olmifon is not FDA-approved for any indications and is considered an off-patent, generic medication. Key safety considerations include potential liver toxicity and interactions with other medications.

Likelihood of approval

12.3% 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).
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	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	ADRAFINIL
Drug class	adrafinil
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of neurotransmitters like messengers that help different parts of the brain talk to each other. Olmifon helps increase the amount of these messengers, which can help improve alertness, energy, and focus. This can be helpful for people who need to stay awake and alert during long periods of time, such as shift workers or people with sleep disorders.

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:

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

Frequently asked questions about Olmifon

What is Olmifon?

Olmifon (ADRAFINIL) is a adrafinil drug.

How does Olmifon work?

Olmifon works by increasing the production of neurotransmitters in the brain, such as dopamine and norepinephrine.

What is the generic name of Olmifon?

ADRAFINIL is the generic (nonproprietary) name of Olmifon.

What drug class is Olmifon in?

Olmifon belongs to the adrafinil class. See all adrafinil drugs at /class/adrafinil.

What development phase is Olmifon in?

Olmifon is in Phase 2.

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

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