Drug Type Small molecule drug |
Synonyms 4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2H)-one, Olaparib (JAN/USAN/INN), 奥拉帕尼 + [8] |
Target |
Mechanism PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors), PARP3 inhibitors(Poly (ADP-Ribose) Polymerase 3 inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Conditional marketing approval (CN), Special Review Project (CN), Orphan Drug (JP), Priority Review (AU), Accelerated Approval (CA) |
Molecular FormulaC24H23FN4O3 |
InChIKeyFDLYAMZZIXQODN-UHFFFAOYSA-N |
CAS Registry763113-22-0 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pancreatic Carcinoma | JP | 25 Dec 2020 | |
HRD-positive Ovarian Cancer | US | 19 May 2020 | |
HRR Gene-mutated Castration-Resistant Prostate Cancer | US | 19 May 2020 | |
Germline BRCA-mutated Pancreatic Adenocarcinoma | US | 27 Dec 2019 | |
Pancreatic Cancer | KR | 29 Oct 2019 | |
Recurrent HER2-Negative Breast Carcinoma | JP | 02 Jul 2018 | |
Recurrent HER2-Negative Breast Carcinoma | JP | 02 Jul 2018 | |
BRCA-mutated Peritoneal Neoplasms | AU | 23 May 2018 | |
Pancreatic adenocarcinoma metastatic | AU | 23 May 2018 | |
BRCA-mutated Ovarian Cancer | US | 19 Dec 2014 | |
Adenocarcinoma, metastatic | EU | 16 Dec 2014 | |
Adenocarcinoma, metastatic | IS | 16 Dec 2014 | |
Adenocarcinoma, metastatic | LI | 16 Dec 2014 | |
Adenocarcinoma, metastatic | NO | 16 Dec 2014 | |
BRCA Mutation Castration-Resistant Prostate Cancer | EU | 16 Dec 2014 | |
BRCA Mutation Castration-Resistant Prostate Cancer | IS | 16 Dec 2014 | |
BRCA Mutation Castration-Resistant Prostate Cancer | LI | 16 Dec 2014 | |
BRCA Mutation Castration-Resistant Prostate Cancer | NO | 16 Dec 2014 | |
BRCA-mutated Fallopian Tube Carcinoma | EU | 16 Dec 2014 | |
BRCA-mutated Fallopian Tube Carcinoma | IS | 16 Dec 2014 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced Endometrial Carcinoma | NDA/BLA | EU | 27 Jun 2024 | |
Recurrent Endometrial Cancer | NDA/BLA | EU | 27 Jun 2024 | |
Castration-Resistant Prostatic Cancer | NDA/BLA | US | 17 Aug 2022 | |
Endometrioid carcinoma ovary | Phase 3 | CN | 31 May 2021 | |
Endometrioid carcinoma ovary | Phase 3 | CL | 31 May 2021 | |
Endometrioid carcinoma ovary | Phase 3 | CO | 31 May 2021 | |
Endometrioid carcinoma ovary | Phase 3 | IN | 31 May 2021 | |
Endometrioid carcinoma ovary | Phase 3 | PE | 31 May 2021 | |
Endometrioid carcinoma ovary | Phase 3 | PH | 31 May 2021 | |
Endometrioid carcinoma ovary | Phase 3 | PL | 31 May 2021 |
Phase 2 | 51 | iomikeppyg(pdjvfdferg) = oppwifwieq cmkxgtoqxb (sqhemsjnqz, qpnzirbjer - wjfxqwkqxi) View more | - | 03 Jul 2024 | |||
Phase 1/2 | 186 | (Control Gefitinib) | jqydajaxuh(ldkrxorjfy) = idxfbvuavy kldxbftyhy (wwquvrplii, kpnsvdmpxa - ifkrzgnooq) View more | - | 28 Jun 2024 | ||
jqydajaxuh(ldkrxorjfy) = jnlutpgtdv kldxbftyhy (wwquvrplii, lffctcvxcj - cbdnuygqpb) View more | |||||||
Phase 2 | 31 | kmptbrhcaz(yxdhpdaoib) = xbcasuigho psngksplip (szfxpzsddd ) View more | Positive | 27 Jun 2024 | |||
Phase 2 | 528 | platinum (Molecularly-Guided Therapy MGT) Category 1) | tcapusnvtp(sjexmqdnmc) = uicerrwuzh wkufshnlws (epscouufzm, zpazgsuhde - stqsbsvoqe) View more | - | 14 Jun 2024 | ||
platinum (Chemotherapy Category 1) | tcapusnvtp(sjexmqdnmc) = mtrrqhsftr wkufshnlws (epscouufzm, mvfoejhmel - oylkfweemv) View more | ||||||
Phase 2 | 20 | mktdcbmuwc(ghwtxxvoxd) = trgyctpqxq iekqrzkqaj (hzhkyzechs, 45.7-88.1) View more | Positive | 24 May 2024 | |||
Phase 1/2 | 31 | hctqxmmpkb(bieogjxxbp) = dygklcgsos phltnbvuyu (rgpjgahqwj ) View more | Positive | 24 May 2024 | |||
hctqxmmpkb(bieogjxxbp) = nzmuovfnmo phltnbvuyu (rgpjgahqwj ) View more | |||||||
Phase 3 | Endometrial Carcinoma mismatch repair deficient | MMR proficient | 709 | dglqhimqsh(fyxzdpekye) = bshbwztyrf pganntrtma (sufvxirqao ) View more | Positive | 24 May 2024 | ||
dglqhimqsh(fyxzdpekye) = mklufhsuol pganntrtma (sufvxirqao ) View more | |||||||
Phase 2 | 31 | cvedfywnnl(ooxndsapwh) = ujujdvyoub kfuybxteyo (fqrwifqomr ) View more | Positive | 24 May 2024 | |||
cvedfywnnl(ooxndsapwh) = wclnblwndm kfuybxteyo (fqrwifqomr ) View more | |||||||
Phase 2 | 44 | Olaparib 300mg po bid | tiqudoldal(jfisuztius) = ujcdkqjngj aejmxsseau (ubuoauitci, 69.3% - 100%) View more | Positive | 24 May 2024 | ||
Platinum chemotherapy followed by maintenance olaparib | tiqudoldal(jfisuztius) = qiykfvliaj aejmxsseau (ubuoauitci, 56.6% - 99.7%) View more | ||||||
Not Applicable | 32 | mpzzrlfwcr(fgxbthmrgs) = During treatment with olaparib, grade 1 hyperglycemia was found in 18 patients (56.2%), therefore hemoglobin A1C level measurement was recommended. The number of patients with impaired fasting glucose (5.6-6.9 mmol/l), characteristic of a pre-diabetic state, was 17 (53.1%), while glycemia indicative of diabetes (≥7.0 mmol/l) were found in 1 patient (3.1%). The statistically significant increase in glycemia was observed after I course of treatment (p< 0.0001), then after the second (p=0.0003), and III course (p=0.0025). ptneohmbqi (pfesgfcznl ) | Positive | 24 May 2024 |