Last reviewed 2026-05-20 · How we verify

CKD-516 inj

Chong Kun Dang Pharmaceutical · Phase 1 active Small molecule ✓ Verified May 2026

CKD-516 inj is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 1 development. Also known as: CKD-516.

CKD-516 is a small molecule used in the treatment of unspecified adult solid tumors, including colorectal cancer. It is administered as an injection, with a phase I clinical trial (NCT01028859) assessing its safety and pharmacokinetic profile in patients with advanced solid cancers.

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-516 inj
Also known as	CKD-516
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.

Competitive intelligence

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

CKD-516 inj CI brief — competitive landscape report
CKD-516 inj updates RSS · CI watch RSS
Chong Kun Dang Pharmaceutical portfolio CI

Frequently asked questions about CKD-516 inj

What is CKD-516 inj?

CKD-516 inj is a Small molecule drug developed by Chong Kun Dang Pharmaceutical.

Who makes CKD-516 inj?

CKD-516 inj is developed by Chong Kun Dang Pharmaceutical (see full Chong Kun Dang Pharmaceutical pipeline at /company/chong-kun-dang-pharmaceutical).

Is CKD-516 inj also known as anything else?

CKD-516 inj is also known as CKD-516.

What development phase is CKD-516 inj in?

CKD-516 inj is in Phase 1.

Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
Also known as: CKD-516

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