Last reviewed 2026-05-31 · How we verify

HSK31679 medium dose

Haisco Pharmaceutical Group Co., Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

HSK31679 medium dose is a Small molecule drug developed by Haisco Pharmaceutical Group Co., Ltd.. It is currently in Phase 2 development.

HSK31679 is a treatment being studied for hypercholesterolemia, with a medium dose being one of the interventions in a clinical trial. The medium dose of HSK31679 is a type of medium-chain triglycerides, according to ChEMBL.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	HSK31679 medium dose
Sponsor	Haisco Pharmaceutical Group Co., Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD） (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:

HSK31679 medium dose CI brief — competitive landscape report
HSK31679 medium dose updates RSS · CI watch RSS
Haisco Pharmaceutical Group Co., Ltd. portfolio CI

Frequently asked questions about HSK31679 medium dose

What is HSK31679 medium dose?

HSK31679 medium dose is a Small molecule drug developed by Haisco Pharmaceutical Group Co., Ltd..

Who makes HSK31679 medium dose?

HSK31679 medium dose is developed by Haisco Pharmaceutical Group Co., Ltd. (see full Haisco Pharmaceutical Group Co., Ltd. pipeline at /company/haisco-pharmaceutical-group-co-ltd).

What development phase is HSK31679 medium dose in?

HSK31679 medium dose is in Phase 2.

Manufacturer: Haisco Pharmaceutical Group Co., Ltd. — full pipeline

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