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DWP16001 Amg
DWP16001 Amg is a Small molecule drug developed by Daewoong Pharmaceutical Co. LTD.. It is currently in Phase 3 development.
DWP16001 is an AMG (likely referring to a specific molecular scaffold or mechanism class) in development by Daewoong Pharmaceutical, currently in Phase 3 trials.
DWP16001 Amg is a Phase 2, double-blind, placebo-controlled study medication for Type 2 Diabetes Mellitus. It is an ICOS ligand inhibitor, classified as an inhibitor drug modality.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | DWP16001 Amg |
|---|---|
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Without publicly available detailed mechanism information, the exact molecular target and mode of action cannot be reliably determined. The drug is in late-stage clinical development, suggesting it has demonstrated sufficient efficacy and safety in earlier phases to warrant Phase 3 evaluation.
Approved indications
Common side effects
Key clinical trials
- Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin (PHASE3)
- The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus. (PHASE3)
- Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM. (PHASE3)
- The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus (PHASE3)
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers (PHASE1)
- Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus (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:
- DWP16001 Amg CI brief — competitive landscape report
- DWP16001 Amg updates RSS · CI watch RSS
- Daewoong Pharmaceutical Co. LTD. portfolio CI
Frequently asked questions about DWP16001 Amg
What is DWP16001 Amg?
How does DWP16001 Amg work?
Who makes DWP16001 Amg?
What development phase is DWP16001 Amg in?
Related
- Manufacturer: Daewoong Pharmaceutical Co. LTD. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing