Last reviewed 2026-06-02 · How we verify

Pyladox (POSATIRELIN)

Phase 2 active Recombinant protein ✓ Verified Jun 2026

Pyladox (generic name: POSATIRELIN) is a posatirelin drug. It is currently in Phase 2 development.

Pyladox (posatirelin) is thought to work by stimulating the release of growth hormone from the pituitary gland.

Pyladox is a protein modality. It is also known by the synonyms POSATIRELIN, POSATIRELINA, and POSATIRELINE.

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	POSATIRELIN
Drug class	posatirelin
Modality	Recombinant protein
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Imagine your body has a 'growth hormone factory' in the pituitary gland. Pyladox helps to stimulate this factory, releasing more growth hormone into the bloodstream. This can help to promote growth and development in certain conditions.

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:

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

Frequently asked questions about Pyladox

What is Pyladox?

Pyladox (POSATIRELIN) is a posatirelin drug.

How does Pyladox work?

Pyladox (posatirelin) is thought to work by stimulating the release of growth hormone from the pituitary gland.

What is the generic name of Pyladox?

POSATIRELIN is the generic (nonproprietary) name of Pyladox.

What drug class is Pyladox in?

Pyladox belongs to the posatirelin class. See all posatirelin drugs at /class/posatirelin.

What development phase is Pyladox in?

Pyladox is in Phase 2.

Drug class: All posatirelin drugs
Therapeutic area: All drugs in Hematology

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