Last reviewed 2026-04-23 · How we verify

Placebo (for D377)

Chong Kun Dang Pharmaceutical · Phase 3 active Small molecule

Placebo (for D377) is a Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 3 development.

Placebo has no active pharmacological mechanism and serves as a control comparator in clinical trials.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Placebo (for D377)
Sponsor	Chong Kun Dang Pharmaceutical
Modality	Small molecule
Phase	Phase 3

Mechanism of action

Placebo is an inert substance used in randomized controlled trials to establish the efficacy of an investigational drug (D377) by comparison. It allows researchers to distinguish genuine drug effects from placebo response and natural disease progression. The placebo arm is essential for determining whether D377 demonstrates statistically significant clinical benefit beyond placebo effect.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia (PHASE3)

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:

Placebo (for D377) CI brief — competitive landscape report
Placebo (for D377) updates RSS · CI watch RSS
Chong Kun Dang Pharmaceutical portfolio CI

Frequently asked questions about Placebo (for D377)

What is Placebo (for D377)?

Placebo (for D377) is a Small molecule drug developed by Chong Kun Dang Pharmaceutical.

How does Placebo (for D377) work?

Placebo has no active pharmacological mechanism and serves as a control comparator in clinical trials.

Who makes Placebo (for D377)?

Placebo (for D377) is developed by Chong Kun Dang Pharmaceutical (see full Chong Kun Dang Pharmaceutical pipeline at /company/chong-kun-dang-pharmaceutical).

What development phase is Placebo (for D377) in?

Placebo (for D377) is in Phase 3.

Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline

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