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Cresto
Cresto is a Small molecule drug developed by Daewoong Pharmaceutical Co. LTD.. It is currently in Phase 1 development.
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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 | Cresto |
|---|---|
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects (Phase 1)
- A Randomized, Open Label, Multiple-Dose, Cross-over Clinical Study to Investigate Pharmacokinetics and Drug-Drug Interaction Between Rosuvastatin and CS-866 in Healthy Male Volunteers (Phase 1)
- A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Compari (Phase 1)
- A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male V (Phase 1)
- Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes (Phase 4)
- Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (Phase 1)
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:
- Cresto CI brief — competitive landscape report
- Cresto updates RSS · CI watch RSS
- Daewoong Pharmaceutical Co. LTD. portfolio CI
Frequently asked questions about Cresto
What is Cresto?
Who makes Cresto?
What development phase is Cresto in?
Related
- Manufacturer: Daewoong Pharmaceutical Co. LTD. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing