Last reviewed 2026-05-28 · How we verify

TC011 single-arm

TICAROS Co., Ltd. · Phase 2 active Biologic ✓ Verified May 2026

TC011 single-arm is a Biologic drug developed by TICAROS Co., Ltd.. It is currently in Phase 2 development.

TC011 is a small molecule being studied in a single-arm, open-label Phase II clinical trial for its efficacy and safety in treating various types of lymphoma, including Follicular Lymphoma, Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma, and High-grade B-cell Lymphoma. The conditions studied in this trial are primarily related to lymphoma, with a specific focus on Relapsed or Refractory Follicular Lymphoma.

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	TC011 single-arm
Sponsor	TICAROS Co., Ltd.
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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:

TC011 single-arm CI brief — competitive landscape report
TC011 single-arm updates RSS · CI watch RSS
TICAROS Co., Ltd. portfolio CI

Frequently asked questions about TC011 single-arm

What is TC011 single-arm?

TC011 single-arm is a Biologic drug developed by TICAROS Co., Ltd..

Who makes TC011 single-arm?

TC011 single-arm is developed by TICAROS Co., Ltd. (see full TICAROS Co., Ltd. pipeline at /company/ticaros-co-ltd).

What development phase is TC011 single-arm in?

TC011 single-arm is in Phase 2.

Manufacturer: TICAROS Co., Ltd. — full pipeline

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