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sapacitabine and seliciclib
sapacitabine and seliciclib is a Combination chemotherapy Small molecule drug developed by Cyclacel Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: CYC682 and CYC202.
Combines a nucleoside analog that disrupts DNA synthesis with a CDK inhibitor that blocks cell cycle progression.
Sapacitabine is a small molecule DNA inhibitor used in the treatment of advanced solid tumors. Seliciclib is also a small molecule DNA inhibitor used in combination with sapacitabine to treat advanced solid tumors.
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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).
| 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 | sapacitabine and seliciclib |
|---|---|
| Also known as | CYC682 and CYC202 |
| Sponsor | Cyclacel Pharmaceuticals, Inc. |
| Drug class | Combination chemotherapy |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Sapacitabine is a nucleoside analog that interferes with DNA replication and repair. Seliciclib (roscovitine) inhibits cyclin-dependent kinases (CDKs), particularly CDK2, CDK7, and CDK9, which are essential for cell cycle progression. The combination aims to synergistically block cancer cell proliferation through complementary mechanisms.
Approved indications
Common side effects
Key clinical trials
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:
- sapacitabine and seliciclib CI brief — competitive landscape report
- sapacitabine and seliciclib updates RSS · CI watch RSS
- Cyclacel Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about sapacitabine and seliciclib
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Related
- Drug class: All Combination chemotherapy drugs
- Manufacturer: Cyclacel Pharmaceuticals, Inc. — full pipeline
- Also known as: CYC682 and CYC202
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing