Last reviewed 2026-04-19 · How we verify

CKD-385 Tab. 1T

Chong Kun Dang Pharmaceutical · Phase 1 active Small molecule

CKD-385 Tab. 1T is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development. Also known as: CKD-385.

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	CKD-385 Tab. 1T
Also known as	CKD-385
Sponsor	Chong Kun Dang Pharmaceutical
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Clinical Trial to Evaluate Pharmacokinetic Profiles and Safety Between CKD-385 and D935 in Healthy 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:

CKD-385 Tab. 1T CI brief — competitive landscape report
CKD-385 Tab. 1T updates RSS · CI watch RSS
Chong Kun Dang Pharmaceutical portfolio CI

Frequently asked questions about CKD-385 Tab. 1T

What is CKD-385 Tab. 1T?

CKD-385 Tab. 1T is a Small molecule drug developed by Chong Kun Dang Pharmaceutical.

Who makes CKD-385 Tab. 1T?

CKD-385 Tab. 1T is developed by Chong Kun Dang Pharmaceutical (see full Chong Kun Dang Pharmaceutical pipeline at /company/chong-kun-dang-pharmaceutical).

Is CKD-385 Tab. 1T also known as anything else?

CKD-385 Tab. 1T is also known as CKD-385.

What development phase is CKD-385 Tab. 1T in?

CKD-385 Tab. 1T is in Phase 1.

Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
Also known as: CKD-385

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