Last reviewed · How we verify

HRG2010 Capsule, Sinemet®, Madopar®

Jiangsu HengRui Medicine Co., Ltd. · Phase 1 active Small molecule ✓ Verified Jun 2026

HRG2010 Capsule, Sinemet®, Madopar® is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 1 development.

HRG2010 Capsule, Sinemet, and Madopar are being studied for their effects on Parkinson's Disease. The relative bioavailability of HRG2010 Capsule was investigated in a study to determine its pharmacokinetics after single dose administration in healthy 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 nameHRG2010 Capsule, Sinemet®, Madopar®
SponsorJiangsu HengRui Medicine Co., Ltd.
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

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 HRG2010 Capsule, Sinemet®, Madopar®

What is HRG2010 Capsule, Sinemet®, Madopar®?

HRG2010 Capsule, Sinemet®, Madopar® is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd..

Who makes HRG2010 Capsule, Sinemet®, Madopar®?

HRG2010 Capsule, Sinemet®, Madopar® is developed by Jiangsu HengRui Medicine Co., Ltd. (see full Jiangsu HengRui Medicine Co., Ltd. pipeline at /company/jiangsu-hengrui-medicine-co-ltd).

What development phase is HRG2010 Capsule, Sinemet®, Madopar® in?

HRG2010 Capsule, Sinemet®, Madopar® is in Phase 1.

Related

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