Last reviewed 2026-05-30 · How we verify

S095029 RDE

Servier Bio-Innovation LLC · Phase 1 active Small molecule ✓ Verified May 2026

S095029 RDE is a Small molecule drug developed by Servier Bio-Innovation LLC. It is currently in Phase 1 development.

S095029 is being studied in a Phase 1b/2 clinical trial for the treatment of Non-small Cell Lung Cancer (NSCLC). The trial is a platform study of select immunotherapy combinations in participants with advanced NSCLC.

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	S095029 RDE
Sponsor	Servier Bio-Innovation LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (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:

S095029 RDE CI brief — competitive landscape report
S095029 RDE updates RSS · CI watch RSS
Servier Bio-Innovation LLC portfolio CI

Frequently asked questions about S095029 RDE

What is S095029 RDE?

S095029 RDE is a Small molecule drug developed by Servier Bio-Innovation LLC.

Who makes S095029 RDE?

S095029 RDE is developed by Servier Bio-Innovation LLC (see full Servier Bio-Innovation LLC pipeline at /company/servier-bio-innovation-llc).

What development phase is S095029 RDE in?

S095029 RDE is in Phase 1.

Manufacturer: Servier Bio-Innovation LLC — full pipeline

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