Last reviewed 2026-04-19 · How we verify

Methyl-P plus GWI Nutrient Formula

K-PAX Pharmaceuticals, Inc. · Phase 2 active Small molecule

Methyl-P plus GWI Nutrient Formula is a Small molecule drug developed by K-PAX Pharmaceuticals, Inc.. It is currently in Phase 2 development. Also known as: KPAX 002.

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	Methyl-P plus GWI Nutrient Formula
Also known as	KPAX 002
Sponsor	K-PAX Pharmaceuticals, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Methylphenidate Plus GWI-Nutrient Formula as a Treatment for Patients With Gulf War Illness (PHASE2)

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:

Methyl-P plus GWI Nutrient Formula CI brief — competitive landscape report
Methyl-P plus GWI Nutrient Formula updates RSS · CI watch RSS
K-PAX Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about Methyl-P plus GWI Nutrient Formula

What is Methyl-P plus GWI Nutrient Formula?

Methyl-P plus GWI Nutrient Formula is a Small molecule drug developed by K-PAX Pharmaceuticals, Inc..

Who makes Methyl-P plus GWI Nutrient Formula?

Methyl-P plus GWI Nutrient Formula is developed by K-PAX Pharmaceuticals, Inc. (see full K-PAX Pharmaceuticals, Inc. pipeline at /company/k-pax-pharmaceuticals-inc).

Is Methyl-P plus GWI Nutrient Formula also known as anything else?

Methyl-P plus GWI Nutrient Formula is also known as KPAX 002.

What development phase is Methyl-P plus GWI Nutrient Formula in?

Methyl-P plus GWI Nutrient Formula is in Phase 2.

Manufacturer: K-PAX Pharmaceuticals, Inc. — full pipeline
Also known as: KPAX 002

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