Last reviewed 2026-05-31 · How we verify

HEC122505MsOH

Sunshine Lake Pharma Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

HEC122505MsOH is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd.. It is currently in Phase 1 development.

HEC122505MsOH is a treatment being studied for Parkinson Disease in a clinical trial. The study, NCT04625361, is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and food effect of HEC122505MsOH tablets in healthy adult subjects.

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	HEC122505MsOH
Sponsor	Sunshine Lake Pharma Co., 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

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects (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:

HEC122505MsOH CI brief — competitive landscape report
HEC122505MsOH updates RSS · CI watch RSS
Sunshine Lake Pharma Co., Ltd. portfolio CI

Frequently asked questions about HEC122505MsOH

What is HEC122505MsOH?

HEC122505MsOH is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd..

Who makes HEC122505MsOH?

HEC122505MsOH is developed by Sunshine Lake Pharma Co., Ltd. (see full Sunshine Lake Pharma Co., Ltd. pipeline at /company/sunshine-lake-pharma-co-ltd).

What development phase is HEC122505MsOH in?

HEC122505MsOH is in Phase 1.

Manufacturer: Sunshine Lake Pharma Co., Ltd. — full pipeline

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