Last reviewed 2026-05-27 · How we verify

SHR3680; SHR3162

Atridia Pty Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

SHR3680; SHR3162 is a Small molecule drug developed by Atridia Pty Ltd.. It is currently in Phase 1 development.

SHR3680 is a small molecule being studied in clinical trials for various types of cancer, including triple-negative breast cancer and prostate cancer. It is part of the FUTURE-Trop2 trial, which is an umbrella trial for first-line precision therapy in patients with metastatic triple-negative 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	SHR3680; SHR3162
Sponsor	Atridia Pty 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 Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC (PHASE2)
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2) (PHASE1, PHASE2)
FUSCC Refractory TNBC Umbrella (FUTURE) (PHASE1, PHASE2)
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (PHASE2)
A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate 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:

SHR3680; SHR3162 CI brief — competitive landscape report
SHR3680; SHR3162 updates RSS · CI watch RSS
Atridia Pty Ltd. portfolio CI

Frequently asked questions about SHR3680; SHR3162

What is SHR3680; SHR3162?

SHR3680; SHR3162 is a Small molecule drug developed by Atridia Pty Ltd..

Who makes SHR3680; SHR3162?

SHR3680; SHR3162 is developed by Atridia Pty Ltd. (see full Atridia Pty Ltd. pipeline at /company/atridia-pty-ltd).

What development phase is SHR3680; SHR3162 in?

SHR3680; SHR3162 is in Phase 1.

Manufacturer: Atridia Pty Ltd. — full pipeline

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