Last reviewed 2026-06-01 · How we verify

MS-553, DS1

MingSight Pharmaceuticals, Inc · Phase 1 active Small molecule ✓ Verified Jun 2026

MS-553, DS1 is a Small molecule drug developed by MingSight Pharmaceuticals, Inc. It is currently in Phase 1 development.

MS-553 is a small molecule selective PKC-β inhibitor being studied in a Phase Ib clinical trial for the treatment of refractory or relapsed CLL (Chronic Lymphocytic Leukemia) and SLL (Small Lymphocytic Lymphoma). The study also involves DS1, but the specific role of DS1 is not specified in the available information.

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	MS-553, DS1
Sponsor	MingSight Pharmaceuticals, Inc
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL/SLL (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:

MS-553, DS1 CI brief — competitive landscape report
MS-553, DS1 updates RSS · CI watch RSS
MingSight Pharmaceuticals, Inc portfolio CI

Frequently asked questions about MS-553, DS1

What is MS-553, DS1?

MS-553, DS1 is a Small molecule drug developed by MingSight Pharmaceuticals, Inc.

Who makes MS-553, DS1?

MS-553, DS1 is developed by MingSight Pharmaceuticals, Inc (see full MingSight Pharmaceuticals, Inc pipeline at /company/mingsight-pharmaceuticals-inc).

What development phase is MS-553, DS1 in?

MS-553, DS1 is in Phase 1.

Manufacturer: MingSight Pharmaceuticals, Inc — full pipeline

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