Last reviewed 2026-05-23 · How we verify

TSC-200-A0201

TScan Therapeutics, Inc. · Phase 1 active Biologic ✓ Verified May 2026 Quality 0/100

TSC-200-A0201 is a Biologic drug developed by TScan Therapeutics, Inc.. It is currently in Phase 1 development.

TSC-200-A0201 is a small molecule being studied in a Phase 1 basket trial for its safety and feasibility in treating patients with various solid tumors, including head and neck cancer, cervical cancer, non-small cell carcinoma, melanoma, and ovarian cancer. The trial, NCT05973487, is evaluating customized autologous TCR-T cell therapies, which include TSC-200-A0201, in patients with locally advanced or metastatic solid tumors.

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	TSC-200-A0201
Sponsor	TScan Therapeutics, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (PHASE1)

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:

TSC-200-A0201 CI brief — competitive landscape report
TSC-200-A0201 updates RSS · CI watch RSS
TScan Therapeutics, Inc. portfolio CI

Frequently asked questions about TSC-200-A0201

What is TSC-200-A0201?

TSC-200-A0201 is a Biologic drug developed by TScan Therapeutics, Inc..

Who makes TSC-200-A0201?

TSC-200-A0201 is developed by TScan Therapeutics, Inc. (see full TScan Therapeutics, Inc. pipeline at /company/tscan-therapeutics-inc).

What development phase is TSC-200-A0201 in?

TSC-200-A0201 is in Phase 1.

Manufacturer: TScan Therapeutics, Inc. — full pipeline

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