Last reviewed 2026-05-24 · How we verify

Folitropin Beta

Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Folitropin Beta is a Small molecule drug developed by Instituto Valenciano de Infertilidad, IVI VALENCIA. It is currently in Phase 1 development. Also known as: PUREGON.

Folitropin Beta is a hydrolytic enzyme used to treat conditions such as infertility and reproductive sterility, particularly in female patients. It works by hydrolyzing globotriosylceramide, a specific molecular target.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Folitropin Beta
Also known as	PUREGON
Sponsor	Instituto Valenciano de Infertilidad, IVI VALENCIA
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Folitropin Beta CI brief — competitive landscape report
Folitropin Beta updates RSS · CI watch RSS
Instituto Valenciano de Infertilidad, IVI VALENCIA portfolio CI

Frequently asked questions about Folitropin Beta

What is Folitropin Beta?

Folitropin Beta is a Small molecule drug developed by Instituto Valenciano de Infertilidad, IVI VALENCIA.

Who makes Folitropin Beta?

Folitropin Beta is developed by Instituto Valenciano de Infertilidad, IVI VALENCIA (see full Instituto Valenciano de Infertilidad, IVI VALENCIA pipeline at /company/instituto-valenciano-de-infertilidad-ivi-valencia).

Is Folitropin Beta also known as anything else?

Folitropin Beta is also known as PUREGON.

What development phase is Folitropin Beta in?

Folitropin Beta is in Phase 1.

Manufacturer: Instituto Valenciano de Infertilidad, IVI VALENCIA — full pipeline
Also known as: PUREGON

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