Last reviewed 2026-04-19 · How we verify

PIROHEPTINE

Phase 2 active Small molecule

PIROHEPTINE is a piroheptine drug. It is currently in Phase 2 development.

Piroheptine is a small molecule that works by interacting with a specific target in the body.

Piroheptine is a small molecule drug in the piroheptine class, but specific details about its development, ownership, and commercial status are not available. Its target and mechanism of action are also unknown. Piroheptine's approved indications, half-life, bioavailability, and generic manufacturers are not specified. As a result, its commercial status and key safety considerations cannot be accurately assessed. Further research is necessary to understand the pharmacology and clinical utility of piroheptine.

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	PIROHEPTINE
Drug class	piroheptine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and piroheptine is a key that fits into one of those locks. When it binds to the lock, it can either block or enhance the activity of the cell, depending on the specific lock and key interaction. This can help to either reduce or increase the activity of certain cellular processes.

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:

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

Frequently asked questions about PIROHEPTINE

What is PIROHEPTINE?

PIROHEPTINE is a piroheptine drug.

How does PIROHEPTINE work?

Piroheptine is a small molecule that works by interacting with a specific target in the body.

What drug class is PIROHEPTINE in?

PIROHEPTINE belongs to the piroheptine class. See all piroheptine drugs at /class/piroheptine.

What development phase is PIROHEPTINE in?

PIROHEPTINE is in Phase 2.

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

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