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DA-5215-R Tab

Dong-A ST Co., Ltd. · Phase 1 active Small molecule ✓ Verified Jun 2026

DA-5215-R Tab is a Small molecule drug developed by Dong-A ST Co., Ltd.. It is currently in Phase 1 development.

DA-5215-R Tab is a medication being studied in a bioequivalence trial, comparing it to DA-5215 Tab. The study, NCT05376085, is an open-label, randomized, single-dose, cross-over study in healthy participants.

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 nameDA-5215-R Tab
SponsorDong-A ST Co., Ltd.
ModalitySmall molecule
PhasePhase 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:

Frequently asked questions about DA-5215-R Tab

What is DA-5215-R Tab?

DA-5215-R Tab is a Small molecule drug developed by Dong-A ST Co., Ltd..

Who makes DA-5215-R Tab?

DA-5215-R Tab is developed by Dong-A ST Co., Ltd. (see full Dong-A ST Co., Ltd. pipeline at /company/dong-a-st-co-ltd).

What development phase is DA-5215-R Tab in?

DA-5215-R Tab is in Phase 1.

Related

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