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Saruparib (AZD5305)
Saruparib (AZD5305) is a PARP inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for BRCA1/2-mutant ovarian cancer, BRCA1/2-mutant breast cancer, Homologous recombination deficient tumors. Also known as: Saruparib, Darolutamide is also known as Nubeqa, AZD5305.
Saruparib is a PARP inhibitor that blocks poly(ADP-ribose) polymerase enzymes to prevent DNA repair and induce cancer cell death.
Saruparib (AZD5305) is a small molecule being studied in clinical trials for various subtypes of lung small cell carcinoma and prostate cancer. It is being investigated in combination with darolutamide and as a standalone treatment, with no treatment serving as a control in some trials.
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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. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Saruparib (AZD5305) |
|---|---|
| Also known as | Saruparib, Darolutamide is also known as Nubeqa, AZD5305 |
| Sponsor | AstraZeneca |
| Drug class | PARP inhibitor |
| Target | PARP1, PARP2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PARP inhibitors like saruparib trap PARP enzymes on DNA damage sites, preventing single-strand break repair and leading to double-strand breaks in cancer cells. This is particularly effective in tumors with BRCA1/2 mutations or homologous recombination deficiency, where alternative DNA repair pathways are compromised. The mechanism exploits synthetic lethality, where PARP inhibition becomes lethal in cells already deficient in homologous recombination repair.
Approved indications
- BRCA1/2-mutant ovarian cancer
- BRCA1/2-mutant breast cancer
- Homologous recombination deficient tumors
Common side effects
- Anemia
- Nausea
- Fatigue
- Thrombocytopenia
- Leukopenia
Key clinical trials
- A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies (PHASE1, PHASE2)
- Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (PHASE3)
- A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation (PHASE3)
- AZD5305 hADME in Patients With Advanced Solid Malignancies (PHASE1)
- Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors (PHASE1, PHASE2)
- Targeted Pathway Inhibition in Patients With Pancreatic Cancer (EARLY_PHASE1)
- A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (PHASE1)
- Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study (PHASE2)
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:
- Saruparib (AZD5305) CI brief — competitive landscape report
- Saruparib (AZD5305) updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Saruparib (AZD5305)
What is Saruparib (AZD5305)?
How does Saruparib (AZD5305) work?
What is Saruparib (AZD5305) used for?
Who makes Saruparib (AZD5305)?
Is Saruparib (AZD5305) also known as anything else?
What drug class is Saruparib (AZD5305) in?
What development phase is Saruparib (AZD5305) in?
What are the side effects of Saruparib (AZD5305)?
What does Saruparib (AZD5305) target?
Related
- Drug class: All PARP inhibitor drugs
- Target: All drugs targeting PARP1, PARP2
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for BRCA1/2-mutant ovarian cancer
- Indication: Drugs for BRCA1/2-mutant breast cancer
- Indication: Drugs for Homologous recombination deficient tumors
- Also known as: Saruparib, Darolutamide is also known as Nubeqa, AZD5305
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing