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Hypidone Hydrochloride tablets

Zhejiang Huahai Pharmaceutical Co., Ltd. · Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 10/100

Hypidone Hydrochloride tablets is a Small molecule drug developed by Zhejiang Huahai Pharmaceutical Co., Ltd.. It is currently in Phase 2 development. Also known as: HHT101.

Hypidone Hydrochloride tablets are used to treat Major Depressive Disorder, as indicated by a clinical study on ClinicalTrials.gov. The mechanism of action of Hypidone Hydrochloride is as a peptidoglycan inhibitor, 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 nameHypidone Hydrochloride tablets
Also known asHHT101
SponsorZhejiang Huahai Pharmaceutical Co., Ltd.
ModalitySmall molecule
PhasePhase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Hypidone Hydrochloride tablets

What is Hypidone Hydrochloride tablets?

Hypidone Hydrochloride tablets is a Small molecule drug developed by Zhejiang Huahai Pharmaceutical Co., Ltd..

Who makes Hypidone Hydrochloride tablets?

Hypidone Hydrochloride tablets is developed by Zhejiang Huahai Pharmaceutical Co., Ltd. (see full Zhejiang Huahai Pharmaceutical Co., Ltd. pipeline at /company/zhejiang-huahai-pharmaceutical-co-ltd).

Is Hypidone Hydrochloride tablets also known as anything else?

Hypidone Hydrochloride tablets is also known as HHT101.

What development phase is Hypidone Hydrochloride tablets in?

Hypidone Hydrochloride tablets is in Phase 2.

Related

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