Last reviewed 2026-05-30 · How we verify

selatinib ditosilate tablets

Qilu Pharmaceutical Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

selatinib ditosilate tablets is a Small molecule drug developed by Qilu Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.

Selatinib ditosilate tablets are a small molecule used in the treatment of advanced breast cancer. They were studied in a Phase Ib clinical trial (NCT01931943) to evaluate their tolerability and pharmacokinetics in patients with advanced breast cancer.

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	selatinib ditosilate tablets
Sponsor	Qilu Pharmaceutical 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

A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer (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:

selatinib ditosilate tablets CI brief — competitive landscape report
selatinib ditosilate tablets updates RSS · CI watch RSS
Qilu Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about selatinib ditosilate tablets

What is selatinib ditosilate tablets?

selatinib ditosilate tablets is a Small molecule drug developed by Qilu Pharmaceutical Co., Ltd..

Who makes selatinib ditosilate tablets?

selatinib ditosilate tablets is developed by Qilu Pharmaceutical Co., Ltd. (see full Qilu Pharmaceutical Co., Ltd. pipeline at /company/qilu-pharmaceutical-co-ltd).

What development phase is selatinib ditosilate tablets in?

selatinib ditosilate tablets is in Phase 1.

Manufacturer: Qilu Pharmaceutical Co., Ltd. — full pipeline

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