Last reviewed 2026-06-01 · How we verify

Pyrisuccideanol (PIRISUDANOL)

Phase 2 active Small molecule ✓ Verified Jun 2026

Pyrisuccideanol (generic name: PIRISUDANOL) is a pirisudanol drug. It is currently in Phase 2 development.

Pirisudanol is thought to work by interacting with a specific molecular target, but its exact mechanism of action is not yet understood.

Pyrisuccideanol is a small molecule. It also goes by the synonyms PIRISUDANOL, PIRISUDANOL, PYRISUCCIDEANOL, and PYRISUCCIDEANOL.

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	PIRISUDANOL
Drug class	pirisudanol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine pirisudanol as a key that fits into a lock on a cell's surface. When it binds to this lock, it can either turn the lock to open the cell to helpful signals or block the lock to prevent harmful signals from entering. However, the exact lock and how pirisudanol interacts with it are still unknown.

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:

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

Frequently asked questions about Pyrisuccideanol

What is Pyrisuccideanol?

Pyrisuccideanol (PIRISUDANOL) is a pirisudanol drug.

How does Pyrisuccideanol work?

Pirisudanol is thought to work by interacting with a specific molecular target, but its exact mechanism of action is not yet understood.

What is the generic name of Pyrisuccideanol?

PIRISUDANOL is the generic (nonproprietary) name of Pyrisuccideanol.

What drug class is Pyrisuccideanol in?

Pyrisuccideanol belongs to the pirisudanol class. See all pirisudanol drugs at /class/pirisudanol.

What development phase is Pyrisuccideanol in?

Pyrisuccideanol is in Phase 2.

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

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