Last reviewed 2026-04-20 · How we verify

Vonedrine (PHENPROMETHAMINE)

Phase 2 active Small molecule

Vonedrine (generic name: PHENPROMETHAMINE) is a phenpromethamine drug. It is currently in Phase 2 development.

Vonedrine works by interacting with the body's central nervous system to produce a stimulant effect.

Vonedrine, also known as PHENPROMETHAMINE, is a small molecule drug in the phenpromethamine class. Its exact target and mechanism of action are unknown, and it has not been approved by the FDA for any indications. The commercial status of Vonedrine is unclear, and it is not known whether it is patented or available as a generic. As a result, key safety considerations and pharmacokinetic properties, such as half-life and bioavailability, are also unknown. Further research is needed to fully understand the properties and potential uses of Vonedrine.

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	PHENPROMETHAMINE
Drug class	phenpromethamine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a computer, and Vonedrine is a software update that makes it run faster and more efficiently. This can help increase alertness and energy, but it can also have negative effects if not used carefully. The exact way Vonedrine achieves this effect is not fully understood, but it is thought to involve changes in the levels and activity of certain chemicals in the brain.

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:

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

Frequently asked questions about Vonedrine

What is Vonedrine?

Vonedrine (PHENPROMETHAMINE) is a phenpromethamine drug.

How does Vonedrine work?

Vonedrine works by interacting with the body's central nervous system to produce a stimulant effect.

What is the generic name of Vonedrine?

PHENPROMETHAMINE is the generic (nonproprietary) name of Vonedrine.

What drug class is Vonedrine in?

Vonedrine belongs to the phenpromethamine class. See all phenpromethamine drugs at /class/phenpromethamine.

What development phase is Vonedrine in?

Vonedrine is in Phase 2.

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

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