Last reviewed · How we verify
CKD-843 dose#1
CKD-843 dose#1 is a Selective Estrogen Receptor Degrader (SERD) Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 3 development for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
CKD-843 is a selective estrogen receptor degrader (SERD) that binds to and degrades the estrogen receptor, blocking estrogen-dependent signaling in hormone-sensitive cancers.
CKD-843 is a treatment being studied for Alopecia and Androgenetic Alopecia in a clinical trial (NCT04805606). The trial is assessing the pharmacokinetic/pharmacodynamic profiles and safety of CKD-843, with multiple intervention arms including CKD-843 A, CKD-843 B, and CKD-843-R.
-
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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | CKD-843 dose#1 |
|---|---|
| Sponsor | Chong Kun Dang Pharmaceutical |
| Drug class | Selective Estrogen Receptor Degrader (SERD) |
| Target | Estrogen Receptor (ER) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CKD-843 functions as a SERD by binding to the estrogen receptor with high affinity and promoting its proteasomal degradation, thereby eliminating both ligand-dependent and ligand-independent estrogen receptor signaling. This mechanism differs from selective estrogen receptor modulators (SERMs) by achieving complete receptor elimination rather than partial antagonism. The drug is designed to overcome resistance mechanisms that develop with standard endocrine therapies in hormone receptor-positive breast cancer.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Common side effects
- Hot flashes
- Nausea
- Fatigue
- Vaginal dryness
- Arthralgia
Key clinical trials
- A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia (PHASE3)
- The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A (PHASE1)
- A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 (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-843 dose#1 CI brief — competitive landscape report
- CKD-843 dose#1 updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about CKD-843 dose#1
What is CKD-843 dose#1?
How does CKD-843 dose#1 work?
What is CKD-843 dose#1 used for?
Who makes CKD-843 dose#1?
What drug class is CKD-843 dose#1 in?
What development phase is CKD-843 dose#1 in?
What are the side effects of CKD-843 dose#1?
What does CKD-843 dose#1 target?
Related
- Drug class: All Selective Estrogen Receptor Degrader (SERD) drugs
- Target: All drugs targeting Estrogen Receptor (ER)
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing