Last reviewed 2026-05-31 · How we verify

225Ac-TR2205 Injection

Xiaorong Sun · Phase 1 active Small molecule ✓ Verified May 2026 Quality 3/100

225Ac-TR2205 Injection is a Small molecule drug developed by Xiaorong Sun. It is currently in Phase 1 development.

The 225Ac-TR2205 Injection is being studied in a clinical trial for the treatment of Advanced Metastatic Triple-negative Breast Cancer (mTNBC). The mechanism of action of 225Ac-TR2205 Injection is currently unknown.

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	225Ac-TR2205 Injection
Sponsor	Xiaorong Sun
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer. (EARLY_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:

225Ac-TR2205 Injection CI brief — competitive landscape report
225Ac-TR2205 Injection updates RSS · CI watch RSS
Xiaorong Sun portfolio CI

Frequently asked questions about 225Ac-TR2205 Injection

What is 225Ac-TR2205 Injection?

225Ac-TR2205 Injection is a Small molecule drug developed by Xiaorong Sun.

Who makes 225Ac-TR2205 Injection?

225Ac-TR2205 Injection is developed by Xiaorong Sun (see full Xiaorong Sun pipeline at /company/xiaorong-sun).

What development phase is 225Ac-TR2205 Injection in?

225Ac-TR2205 Injection is in Phase 1.

Manufacturer: Xiaorong Sun — full pipeline

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