Last reviewed 2026-05-28 · How we verify

Probilin (PIPROZOLIN)

Phase 2 active Small molecule

Probilin (generic name: PIPROZOLIN) is a piprozolin drug. It is currently in Phase 2 development.

Piprozolin is believed to work by modulating certain biological pathways.

Piprozolin, also known as Probilin, is a small molecule drug in the piprozolin class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating certain biological pathways. Piprozolin's commercial status and approved indications are unclear, and it is not known whether it is FDA-approved or off-patent. Further research is needed to fully understand its effects and potential uses. As a result, key safety considerations and pharmacokinetic properties, such as half-life and bioavailability, are also unknown.

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	PIPROZOLIN
Drug class	piprozolin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that unlocks a specific process in the body. By fitting into a particular spot, it can either turn the process on or off, or even change how it works. This can have different effects depending on the process and where it's happening in the body.

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:

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

Frequently asked questions about Probilin

What is Probilin?

Probilin (PIPROZOLIN) is a piprozolin drug.

How does Probilin work?

Piprozolin is believed to work by modulating certain biological pathways.

What is the generic name of Probilin?

PIPROZOLIN is the generic (nonproprietary) name of Probilin.

What drug class is Probilin in?

Probilin belongs to the piprozolin class. See all piprozolin drugs at /class/piprozolin.

What development phase is Probilin in?

Probilin is in Phase 2.

Drug class: All piprozolin drugs
Therapeutic area: All drugs in Other

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