Last reviewed 2026-06-01 · How we verify

Prolintan (PROLINTANE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Prolintan (generic name: PROLINTANE) is a prolintane drug. It is currently in Phase 2 development.

Prolintan works by increasing the release of neurotransmitters in the brain, such as norepinephrine, serotonin, and dopamine.

Prolintan is a small molecule with the synonyms PROLINTAN, PROLINTANE, PROLINTANO.

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	PROLINTANE
Drug class	prolintane
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of neurotransmitters like messengers in your brain. Prolintan helps these messengers get released more easily, which can help improve alertness, focus, and energy. This can be helpful for people who feel tired or sluggish.

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:

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

Frequently asked questions about Prolintan

What is Prolintan?

Prolintan (PROLINTANE) is a prolintane drug.

How does Prolintan work?

Prolintan works by increasing the release of neurotransmitters in the brain, such as norepinephrine, serotonin, and dopamine.

What is the generic name of Prolintan?

PROLINTANE is the generic (nonproprietary) name of Prolintan.

What drug class is Prolintan in?

Prolintan belongs to the prolintane class. See all prolintane drugs at /class/prolintane.

What development phase is Prolintan in?

Prolintan is in Phase 2.

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

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