LAU-7b for 3 cycles

Laurent Pharmaceuticals Inc. · Phase 2 active Small molecule Quality 0/100

LAU-7b for 3 cycles is a Small molecule drug developed by Laurent Pharmaceuticals Inc.. It is currently in Phase 2 development. Also known as: fenretinide.

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	LAU-7b for 3 cycles
Also known as	fenretinide
Sponsor	Laurent Pharmaceuticals Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Study of LAU-7b for the Treatment of Long COVID in Adults (PHASE2, PHASE3)

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:

• LAU-7b for 3 cycles CI brief — competitive landscape report
• LAU-7b for 3 cycles updates RSS · CI watch RSS
• Laurent Pharmaceuticals Inc. portfolio CI

Frequently asked questions about LAU-7b for 3 cycles

What is LAU-7b for 3 cycles?

LAU-7b for 3 cycles is a Small molecule drug developed by Laurent Pharmaceuticals Inc..

Who makes LAU-7b for 3 cycles?

LAU-7b for 3 cycles is developed by Laurent Pharmaceuticals Inc. (see full Laurent Pharmaceuticals Inc. pipeline at /company/laurent-pharmaceuticals-inc).

Is LAU-7b for 3 cycles also known as anything else?

LAU-7b for 3 cycles is also known as fenretinide.

What development phase is LAU-7b for 3 cycles in?

LAU-7b for 3 cycles is in Phase 2.

Related

• Manufacturer: Laurent Pharmaceuticals Inc. — full pipeline
• Also known as: fenretinide