MGTA-456

Magenta Therapeutics, Inc. · Phase 2 active Small molecule

MGTA-456 is a Small molecule drug developed by Magenta Therapeutics, Inc.. It is currently in Phase 2 development. Also known as: HSC835.

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	MGTA-456
Also known as	HSC835
Sponsor	Magenta Therapeutics, 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

• Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy (PHASE2)
• MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT) (PHASE2)
• A Follow-up Study in Patients With Inherited Metabolic Disorders (IMD) Who Underwent Hematopoietic Stem Cell Transplantation (HSCT) With MGTA-456

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:

• MGTA-456 CI brief — competitive landscape report
• MGTA-456 updates RSS · CI watch RSS
• Magenta Therapeutics, Inc. portfolio CI

Frequently asked questions about MGTA-456

What is MGTA-456?

MGTA-456 is a Small molecule drug developed by Magenta Therapeutics, Inc..

Who makes MGTA-456?

MGTA-456 is developed by Magenta Therapeutics, Inc. (see full Magenta Therapeutics, Inc. pipeline at /company/magenta-therapeutics-inc).

Is MGTA-456 also known as anything else?

MGTA-456 is also known as HSC835.

What development phase is MGTA-456 in?

MGTA-456 is in Phase 2.

Related

• Manufacturer: Magenta Therapeutics, Inc. — full pipeline
• Also known as: HSC835