SOM230C

Patrick Y. Wen, MD · Phase 2 active Small molecule

SOM230C is a Small molecule drug developed by Patrick Y. Wen, MD. It is currently in Phase 2 development. Also known as: pasireotide LAR.

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	SOM230C
Also known as	pasireotide LAR
Sponsor	Patrick Y. Wen, MD
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Monthly SOM230C for Recurrent or Progressive Meningioma (PHASE2)
• Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma (PHASE2)
• Phase I Trial of Combination of FOLFIRI and SOM 230 (PHASE1)

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:

• SOM230C CI brief — competitive landscape report
• SOM230C updates RSS · CI watch RSS
• Patrick Y. Wen, MD portfolio CI

Frequently asked questions about SOM230C

What is SOM230C?

SOM230C is a Small molecule drug developed by Patrick Y. Wen, MD.

Who makes SOM230C?

SOM230C is developed by Patrick Y. Wen, MD (see full Patrick Y. Wen, MD pipeline at /company/patrick-y-wen-md).

Is SOM230C also known as anything else?

SOM230C is also known as pasireotide LAR.

What development phase is SOM230C in?

SOM230C is in Phase 2.

Related

• Manufacturer: Patrick Y. Wen, MD — full pipeline
• Also known as: pasireotide LAR