Last reviewed 2026-04-19 · How we verify

BORNAPRINE

Phase 2 active Small molecule

BORNAPRINE is a bornaprine drug. It is currently in Phase 2 development.

Bornaprine is thought to work by modulating the activity of certain neurotransmitters in the brain.

Bornaprine is a small molecule drug in the bornaprine class, but its target and commercial status are unknown. It is not clear if it has been approved by the FDA or if it is patented or generic. The drug's pharmacokinetic properties, such as half-life and bioavailability, are also unknown. Further research is needed to understand its clinical use and safety profile.

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	BORNAPRINE
Drug class	bornaprine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

This means that it helps to regulate the balance of chemicals in the brain that are involved in mood and other functions. By doing so, it may help to alleviate symptoms of certain conditions, although its exact mechanism of action is not well understood.

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:

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

Frequently asked questions about BORNAPRINE

What is BORNAPRINE?

BORNAPRINE is a bornaprine drug.

How does BORNAPRINE work?

Bornaprine is thought to work by modulating the activity of certain neurotransmitters in the brain.

What drug class is BORNAPRINE in?

BORNAPRINE belongs to the bornaprine class. See all bornaprine drugs at /class/bornaprine.

What development phase is BORNAPRINE in?

BORNAPRINE is in Phase 2.

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

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