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Olaparib; 177Lu-DOTATATE
Olaparib; 177Lu-DOTATATE is a Small molecule drug developed by Fundación de investigación HM. It is currently in Phase 2 development.
Olaparib is a small molecule PARP 1, 2, and 3 inhibitor used in the treatment of various solid tumor cancers, including medulloblastoma, high risk neuroblastoma, high grade gliomas, and meningioma. It is often combined with 177Lu-DOTATATE, a radioactive peptide, for the treatment of recurrent or relapsed solid tumors in children and adolescents.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Olaparib; 177Lu-DOTATATE |
|---|---|
| Sponsor | Fundación de investigación HM |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET) (PHASE1, PHASE2)
- Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors (PHASE1)
- Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). (PHASE2)
- 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours (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:
- Olaparib; 177Lu-DOTATATE CI brief — competitive landscape report
- Olaparib; 177Lu-DOTATATE updates RSS · CI watch RSS
- Fundación de investigación HM portfolio CI
Frequently asked questions about Olaparib; 177Lu-DOTATATE
What is Olaparib; 177Lu-DOTATATE?
Who makes Olaparib; 177Lu-DOTATATE?
What development phase is Olaparib; 177Lu-DOTATATE in?
Related
- Manufacturer: Fundación de investigación HM — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing