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D326, D337 and D013
D326, D337 and D013 is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development. Also known as: CKD-386 Reference.
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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 | D326, D337 and D013 |
|---|---|
| Also known as | CKD-386 Reference |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg (PHASE1)
- Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions (PHASE1)
- A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(3) 80/20/10mg (PHASE1)
- A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) 80/20/10mg (PHASE1)
- Clinical Trial to Evaluate the Efficacy and Safety of CKD-386 (PHASE3)
- A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) (PHASE1)
- Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet (PHASE3)
- A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers (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:
- D326, D337 and D013 CI brief — competitive landscape report
- D326, D337 and D013 updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about D326, D337 and D013
What is D326, D337 and D013?
Who makes D326, D337 and D013?
Is D326, D337 and D013 also known as anything else?
What development phase is D326, D337 and D013 in?
Related
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Also known as: CKD-386 Reference
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing