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KW-6356 High Dose
KW-6356 High Dose is a Small molecule drug developed by Kyowa Kirin Co., Ltd.. It is currently in Phase 1 development.
KW-6356 is a small molecule being studied in a Phase 2b clinical trial for the treatment of Parkinson's Disease in patients already receiving levodopa-containing preparations. The trial is comparing the efficacy of a high dose of KW-6356 to a low dose and a placebo.
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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).
| 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 | KW-6356 High Dose |
|---|---|
| Sponsor | Kyowa Kirin Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations (PHASE2)
- A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects (PHASE1)
- A Study of KW-6356 in Subjects With Early Parkinson's Disease (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:
- KW-6356 High Dose CI brief — competitive landscape report
- KW-6356 High Dose updates RSS · CI watch RSS
- Kyowa Kirin Co., Ltd. portfolio CI
Frequently asked questions about KW-6356 High Dose
What is KW-6356 High Dose?
Who makes KW-6356 High Dose?
What development phase is KW-6356 High Dose in?
Related
- Manufacturer: Kyowa Kirin Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing