Last reviewed 2026-05-31 · How we verify

Mitizodone Phosphate tablets

Sunshine Lake Pharma Co., Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

Mitizodone Phosphate tablets is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd.. It is currently in Phase 2 development. Also known as: HEC113995PA•H2O.

Mitizodone Phosphate tablets are a small molecule used in the treatment of Major Depressive Disorder. They are administered as part of a Phase II/III clinical trial to evaluate their efficacy and safety in patients with this condition.

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	Mitizodone Phosphate tablets
Also known as	HEC113995PA•H2O
Sponsor	Sunshine Lake Pharma 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

The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder (PHASE2, PHASE3)

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:

Mitizodone Phosphate tablets CI brief — competitive landscape report
Mitizodone Phosphate tablets updates RSS · CI watch RSS
Sunshine Lake Pharma Co., Ltd. portfolio CI

Frequently asked questions about Mitizodone Phosphate tablets

What is Mitizodone Phosphate tablets?

Mitizodone Phosphate tablets is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd..

Who makes Mitizodone Phosphate tablets?

Mitizodone Phosphate tablets is developed by Sunshine Lake Pharma Co., Ltd. (see full Sunshine Lake Pharma Co., Ltd. pipeline at /company/sunshine-lake-pharma-co-ltd).

Is Mitizodone Phosphate tablets also known as anything else?

Mitizodone Phosphate tablets is also known as HEC113995PA•H2O.

What development phase is Mitizodone Phosphate tablets in?

Mitizodone Phosphate tablets is in Phase 2.

Manufacturer: Sunshine Lake Pharma Co., Ltd. — full pipeline
Also known as: HEC113995PA•H2O

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