Lanreotide PRF

Ipsen · Phase 1 active Small molecule

Lanreotide PRF is a Small molecule drug developed by Ipsen. It is currently in Phase 1 development. Also known as: Lanreotide acetate.

Lanreotide PRF is a somatostatin receptor 5 agonist used to treat acromegaly. It belongs to the drug class of agonists and acts on the somatostatin receptor type 5, a protein modality.

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	Lanreotide PRF
Also known as	Lanreotide acetate
Sponsor	Ipsen
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly (PHASE1, PHASE2)

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:

• Lanreotide PRF CI brief — competitive landscape report
• Lanreotide PRF updates RSS · CI watch RSS
• Ipsen portfolio CI

Frequently asked questions about Lanreotide PRF

What is Lanreotide PRF?

Lanreotide PRF is a Small molecule drug developed by Ipsen.

Who makes Lanreotide PRF?

Lanreotide PRF is developed by Ipsen (see full Ipsen pipeline at /company/ipsen).

Is Lanreotide PRF also known as anything else?

Lanreotide PRF is also known as Lanreotide acetate.

What development phase is Lanreotide PRF in?

Lanreotide PRF is in Phase 1.

Related

• Manufacturer: Ipsen — full pipeline
• Also known as: Lanreotide acetate