Last reviewed 2026-05-27 · How we verify

Simmiparib

Shanghai Acebright Pharmaceuticals Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

Simmiparib is a Small molecule drug developed by Shanghai Acebright Pharmaceuticals Co., Ltd.. It is currently in Phase 1 development. Also known as: SMOCL-9112.

Simmiparib is a small molecule being studied in a clinical trial for the treatment of malignant advanced solid tumors. The trial, NCT02993913, is assessing the safety, tolerability, and pharmacokinetics of simmiparib in patients with this condition.

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	Simmiparib
Also known as	SMOCL-9112
Sponsor	Shanghai Acebright Pharmaceuticals Co., Ltd.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety, Tolerability and Pharmacokinetics of Simmiparib in Patients With Malignant Advanced Solid Tumor (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:

Simmiparib CI brief — competitive landscape report
Simmiparib updates RSS · CI watch RSS
Shanghai Acebright Pharmaceuticals Co., Ltd. portfolio CI

Frequently asked questions about Simmiparib

What is Simmiparib?

Simmiparib is a Small molecule drug developed by Shanghai Acebright Pharmaceuticals Co., Ltd..

Who makes Simmiparib?

Simmiparib is developed by Shanghai Acebright Pharmaceuticals Co., Ltd. (see full Shanghai Acebright Pharmaceuticals Co., Ltd. pipeline at /company/shanghai-acebright-pharmaceuticals-co-ltd).

Is Simmiparib also known as anything else?

Simmiparib is also known as SMOCL-9112.

What development phase is Simmiparib in?

Simmiparib is in Phase 1.

Manufacturer: Shanghai Acebright Pharmaceuticals Co., Ltd. — full pipeline
Therapeutic area: All drugs in Other
Also known as: SMOCL-9112

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