Last reviewed 2026-05-23 · How we verify

M3814 200 mg

EMD Serono Research & Development Institute, Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 20/100

M3814 200 mg is a Small molecule drug developed by EMD Serono Research & Development Institute, Inc.. It is currently in Phase 1 development. Also known as: Peposertib, MSC2490484.

M3814 is a small molecule inhibitor, specifically identified by the synonym MG-S-2525 in ChEMBL. It has been studied in clinical trials for the treatment of Advanced Solid Tumors and Chronic Lymphocytic Leukemia, with doses including 100 mg, 200 mg, and 300 mg of M3814.

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	M3814 200 mg
Also known as	Peposertib, MSC2490484
Sponsor	EMD Serono Research & Development Institute, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Fatigue
Constipation
Oral pain
Stomatitis
Decreased appetite
Dry mouth
Dysphagia
Oral candidiasis
Radiation skin injury
Headache
Ear haemorrhage
Nausea

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:

M3814 200 mg CI brief — competitive landscape report
M3814 200 mg updates RSS · CI watch RSS
EMD Serono Research & Development Institute, Inc. portfolio CI

Frequently asked questions about M3814 200 mg

What is M3814 200 mg?

M3814 200 mg is a Small molecule drug developed by EMD Serono Research & Development Institute, Inc..

Who makes M3814 200 mg?

M3814 200 mg is developed by EMD Serono Research & Development Institute, Inc. (see full EMD Serono Research & Development Institute, Inc. pipeline at /company/emd-serono-research-development-institute-inc).

Is M3814 200 mg also known as anything else?

M3814 200 mg is also known as Peposertib, MSC2490484.

What development phase is M3814 200 mg in?

M3814 200 mg is in Phase 1.

What are the side effects of M3814 200 mg?

Common side effects of M3814 200 mg include Fatigue, Constipation, Oral pain, Stomatitis, Decreased appetite, Dry mouth.

Manufacturer: EMD Serono Research & Development Institute, Inc. — full pipeline
Also known as: Peposertib, MSC2490484

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