Last reviewed 2026-05-27 · How we verify

T-ACE Oil

T-ACE Medical Co., Ltd · Phase 1 active Small molecule ✓ Verified May 2026

T-ACE Oil is a Small molecule drug developed by T-ACE Medical Co., Ltd. It is currently in Phase 1 development.

T-ACE Oil is being studied in a Phase I/II clinical trial for the treatment of Hepatocellular Carcinoma. The trial involves comparing T-ACE Oil to Lipiodol in patients with Hepatocellular Carcinoma through trans-catheter arterial embolization or chemoembolization.

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	T-ACE Oil
Sponsor	T-ACE Medical Co., Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma (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:

T-ACE Oil CI brief — competitive landscape report
T-ACE Oil updates RSS · CI watch RSS
T-ACE Medical Co., Ltd portfolio CI

Frequently asked questions about T-ACE Oil

What is T-ACE Oil?

T-ACE Oil is a Small molecule drug developed by T-ACE Medical Co., Ltd.

Who makes T-ACE Oil?

T-ACE Oil is developed by T-ACE Medical Co., Ltd (see full T-ACE Medical Co., Ltd pipeline at /company/t-ace-medical-co-ltd).

What development phase is T-ACE Oil in?

T-ACE Oil is in Phase 1.

Manufacturer: T-ACE Medical Co., Ltd — full pipeline

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