Last reviewed 2026-05-25 · How we verify

TBI-1501

Takara Bio Inc. · Phase 1 active Biologic ✓ Verified May 2026 Quality 0/100

TBI-1501 is a Biologic drug developed by Takara Bio Inc.. It is currently in Phase 1 development.

TBI-1501 is a small molecule being studied in a multicenter Phase I/II clinical trial for the treatment of relapsed or refractory Acute Adult Lymphoblastic Leukemia. The trial is sponsored by Takara Bio Inc. and focuses on CD19+ B-acute Lymphoblastic Leukemia.

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	TBI-1501
Sponsor	Takara Bio Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia (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:

TBI-1501 CI brief — competitive landscape report
TBI-1501 updates RSS · CI watch RSS
Takara Bio Inc. portfolio CI

Frequently asked questions about TBI-1501

What is TBI-1501?

TBI-1501 is a Biologic drug developed by Takara Bio Inc..

Who makes TBI-1501?

TBI-1501 is developed by Takara Bio Inc. (see full Takara Bio Inc. pipeline at /company/takara-bio-inc).

What development phase is TBI-1501 in?

TBI-1501 is in Phase 1.

Manufacturer: Takara Bio Inc. — full pipeline

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