Last reviewed 2026-04-19 · How we verify

DEXTROFEMINE

Phase 2 active Small molecule

DEXTROFEMINE is a dextrofemine drug. It is currently in Phase 2 development.

DEXTROFEMINE is a stimulant that works by increasing the levels of certain neurotransmitters in the brain.

DEXTROFEMINE is a small molecule drug belonging to the dextrofemine class, but its original developer and current owner are unknown. Its target and approved indications are also not specified. The commercial status of DEXTROFEMINE is unclear, with unknown patent status and generic manufacturers. Key safety considerations are not available due to the lack of FDA approval and available information. Further research is necessary to understand the pharmacology and clinical use of DEXTROFEMINE.

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	DEXTROFEMINE
Drug class	dextrofemine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a city with many different streets and intersections. DEXTROFEMINE helps to increase the traffic flow of certain important chemicals, called neurotransmitters, that allow different parts of the brain to communicate with each other. This can help to improve focus, attention, and energy, but it can also have negative effects if not used carefully.

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:

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

Frequently asked questions about DEXTROFEMINE

What is DEXTROFEMINE?

DEXTROFEMINE is a dextrofemine drug.

How does DEXTROFEMINE work?

DEXTROFEMINE is a stimulant that works by increasing the levels of certain neurotransmitters in the brain.

What drug class is DEXTROFEMINE in?

DEXTROFEMINE belongs to the dextrofemine class. See all dextrofemine drugs at /class/dextrofemine.

What development phase is DEXTROFEMINE in?

DEXTROFEMINE is in Phase 2.

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

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