Last reviewed 2026-04-20 · How we verify

Nimaol (OCTAMOXIN)

Phase 2 active Small molecule

Nimaol (generic name: OCTAMOXIN) is a octamoxin drug. It is currently in Phase 2 development.

Nimaol works by interacting with a specific target in the body to produce its therapeutic effect.

Nimaol, also known as OCTAMOXIN, is a small molecule drug of the octamoxin class. Its target and exact mechanism of action are unknown. It is not clear if Nimaol is FDA-approved or has any approved indications. The commercial status of Nimaol, including whether it is patented or generic, is also unknown. Further research is needed to understand the safety considerations and pharmacokinetic properties of Nimaol.

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	OCTAMOXIN
Drug class	octamoxin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Unfortunately, the exact mechanism of action of Nimaol is not well understood, but it is thought to involve binding to a specific protein or receptor in the body. This binding can alter the activity of the protein or receptor, leading to changes in the body's normal functioning. As a result, Nimaol may help to treat certain conditions by modifying the body's response to a particular stimulus.

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:

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

Frequently asked questions about Nimaol

What is Nimaol?

Nimaol (OCTAMOXIN) is a octamoxin drug.

How does Nimaol work?

Nimaol works by interacting with a specific target in the body to produce its therapeutic effect.

What is the generic name of Nimaol?

OCTAMOXIN is the generic (nonproprietary) name of Nimaol.

What drug class is Nimaol in?

Nimaol belongs to the octamoxin class. See all octamoxin drugs at /class/octamoxin.

What development phase is Nimaol in?

Nimaol is in Phase 2.

Drug class: All octamoxin drugs
Therapeutic area: All drugs in Other

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