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Pidnarulex
Pidnarulex is a Small molecule drug developed by National Cancer Institute (NCI). It is currently in Phase 1 development. Also known as: CX-5461, CX5461, Pol I Inhibitor CX5461, RNA Pol I Inhibitor CX5461.
Pidnarulex is a small molecule used in clinical trials for various breast cancer conditions, including Anatomic Stage III and IV Breast Cancer, Invasive Breast Carcinoma, and Metastatic Breast Carcinoma. It has been studied in trials involving procedures such as biopsy, biospecimen collection, and echocardiography testing.
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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 | Pidnarulex |
|---|---|
| Also known as | CX-5461, CX5461, Pol I Inhibitor CX5461, RNA Pol I Inhibitor CX5461 |
| Sponsor | National Cancer Institute (NCI) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461) in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer (PHASE1, PHASE2)
- Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer (PHASE1)
- Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene (PHASE1, PHASE2)
- Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers (PHASE1)
- Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation (PHASE1)
- Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer (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:
- Pidnarulex CI brief — competitive landscape report
- Pidnarulex updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about Pidnarulex
What is Pidnarulex?
Who makes Pidnarulex?
Is Pidnarulex also known as anything else?
What development phase is Pidnarulex in?
Related
- Manufacturer: National Cancer Institute (NCI) — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CX-5461, CX5461, Pol I Inhibitor CX5461, RNA Pol I Inhibitor CX5461
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing