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DA-1229_01 fast
DA-1229_01 fast is a Small molecule drug developed by Dong-A ST Co., Ltd.. It is currently in Phase 1 development.
DA-1229_01 is a small molecule used in a bioequivalence study to investigate its effects in fasting state conditions, including Type 2 Diabetes. The study, NCT03939143, compares the bioequivalence of DA-1229_01 with Sugamet SR Tab 5/1000mg in healthy subjects and those with Type 2 Diabetes Mellitus.
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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 | DA-1229_01 fast |
|---|---|
| Sponsor | Dong-A ST Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State (PHASE1)
- Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State (PHASE1)
- Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State (PHASE1)
- A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State (PHASE1)
- A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 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:
- DA-1229_01 fast CI brief — competitive landscape report
- DA-1229_01 fast updates RSS · CI watch RSS
- Dong-A ST Co., Ltd. portfolio CI
Frequently asked questions about DA-1229_01 fast
What is DA-1229_01 fast?
Who makes DA-1229_01 fast?
What development phase is DA-1229_01 fast in?
Related
- Manufacturer: Dong-A ST Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing