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Test drug 1
Test drug 1 is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development. Also known as: CKD-385 64 mg formulation I (878mg), CKD-385 64 mg formulation I.
Test drug 1 is not mentioned in the provided facts. However, based on the information, the study NCT04791397 is evaluating the effect of Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy on vascular stiffness and liver elasticity in patients with Metabolic Syndrome.
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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 | Test drug 1 |
|---|---|
| Also known as | CKD-385 64 mg formulation I (878mg), CKD-385 64 mg formulation I |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Screening and Multiple Intervention on Lung Epidemics (PHASE2)
- Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (PHASE3)
- Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer (PHASE1)
- Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial (PHASE1)
- Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) (PHASE2)
- Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML (PHASE1)
- Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors (PHASE1, PHASE2)
- Adenosine 2A Receptor Antagonism and AIH in ALS (PHASE1, 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:
- Test drug 1 CI brief — competitive landscape report
- Test drug 1 updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about Test drug 1
What is Test drug 1?
Who makes Test drug 1?
Is Test drug 1 also known as anything else?
What development phase is Test drug 1 in?
Related
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Also known as: CKD-385 64 mg formulation I (878mg), CKD-385 64 mg formulation I
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing