Last reviewed 2026-05-31 · How we verify

DW4421

Daewon Pharmaceutical Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

DW4421 is a Small molecule drug developed by Daewon Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.

DW4421 is a drug being studied in clinical trials for its safety and pharmacokinetics, particularly in relation to interactions with other medications. The conditions being studied in these trials include GERD (Gastroesophageal Reflux Disease) and involve healthy adult volunteers.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	DW4421
Sponsor	Daewon Pharmaceutical Co., Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

DW4421 CI brief — competitive landscape report
DW4421 updates RSS · CI watch RSS
Daewon Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about DW4421

What is DW4421?

DW4421 is a Small molecule drug developed by Daewon Pharmaceutical Co., Ltd..

Who makes DW4421?

DW4421 is developed by Daewon Pharmaceutical Co., Ltd. (see full Daewon Pharmaceutical Co., Ltd. pipeline at /company/daewon-pharmaceutical-co-ltd).

What development phase is DW4421 in?

DW4421 is in Phase 1.

Manufacturer: Daewon Pharmaceutical Co., Ltd. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing