Last update 25 Jul 2024

Olaparib

Overview

Basic Info

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]
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)
Originator Organization
Drug Highest PhaseApproved
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)
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Structure

Molecular FormulaC24H23FN4O3
InChIKeyFDLYAMZZIXQODN-UHFFFAOYSA-N
CAS Registry763113-22-0

External Link

KEGGWikiATCDrug Bank
D09730Olaparib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Endometrial CarcinomaNDA/BLA
EU
27 Jun 2024
Recurrent Endometrial CancerNDA/BLA
EU
27 Jun 2024
Castration-Resistant Prostatic CancerNDA/BLA
US
17 Aug 2022
Endometrioid carcinoma ovaryPhase 3
CN
31 May 2021
Endometrioid carcinoma ovaryPhase 3
CL
31 May 2021
Endometrioid carcinoma ovaryPhase 3
CO
31 May 2021
Endometrioid carcinoma ovaryPhase 3
IN
31 May 2021
Endometrioid carcinoma ovaryPhase 3
PE
31 May 2021
Endometrioid carcinoma ovaryPhase 3
PH
31 May 2021
Endometrioid carcinoma ovaryPhase 3
PL
31 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
51
iomikeppyg(pdjvfdferg) = oppwifwieq cmkxgtoqxb (sqhemsjnqz, qpnzirbjer - wjfxqwkqxi)
-
03 Jul 2024
Phase 1/2
186
(Control Gefitinib)
jqydajaxuh(ldkrxorjfy) = idxfbvuavy kldxbftyhy (wwquvrplii, kpnsvdmpxa - ifkrzgnooq)
-
28 Jun 2024
(Experimental: Gefitinib in Combination With Olaparib)
jqydajaxuh(ldkrxorjfy) = jnlutpgtdv kldxbftyhy (wwquvrplii, lffctcvxcj - cbdnuygqpb)
Phase 2
31
kmptbrhcaz(yxdhpdaoib) = xbcasuigho psngksplip (szfxpzsddd )
Positive
27 Jun 2024
Phase 2
528
platinum
(Molecularly-Guided Therapy MGT) Category 1)
tcapusnvtp(sjexmqdnmc) = uicerrwuzh wkufshnlws (epscouufzm, zpazgsuhde - stqsbsvoqe)
-
14 Jun 2024
platinum
(Chemotherapy Category 1)
tcapusnvtp(sjexmqdnmc) = mtrrqhsftr wkufshnlws (epscouufzm, mvfoejhmel - oylkfweemv)
Phase 2
Ovarian Epithelial Carcinoma
Neoadjuvant
HRD Positive | BRCA1 Mutation | BRCA2 Mutation
20
mktdcbmuwc(ghwtxxvoxd) = trgyctpqxq iekqrzkqaj (hzhkyzechs, 45.7-88.1)
Positive
24 May 2024
Phase 1/2
Recurrent Endometrial Cancer
HRD Positive ...
31
Olaparib + metronomic cyclophosphamide + metformin
hctqxmmpkb(bieogjxxbp) = dygklcgsos phltnbvuyu (rgpjgahqwj )
Positive
24 May 2024
Olaparib + metronomic cyclophosphamide + metformin
(MSI-high)
hctqxmmpkb(bieogjxxbp) = nzmuovfnmo phltnbvuyu (rgpjgahqwj )
Phase 3
Endometrial Carcinoma
mismatch repair deficient | MMR proficient
709
dglqhimqsh(fyxzdpekye) = bshbwztyrf pganntrtma (sufvxirqao )
Positive
24 May 2024
dglqhimqsh(fyxzdpekye) = mklufhsuol pganntrtma (sufvxirqao )
Phase 2
31
cvedfywnnl(ooxndsapwh) = ujujdvyoub kfuybxteyo (fqrwifqomr )
Positive
24 May 2024
cvedfywnnl(ooxndsapwh) = wclnblwndm kfuybxteyo (fqrwifqomr )
Phase 2
Recurrent ovarian cancer
Neoadjuvant
wtBRCA1/2 | germlineBRCA1/2mutation
44
Olaparib 300mg po bid
tiqudoldal(jfisuztius) = ujcdkqjngj aejmxsseau (ubuoauitci, 69.3% - 100%)
Positive
24 May 2024
Platinum chemotherapy followed by maintenance olaparib
tiqudoldal(jfisuztius) = qiykfvliaj aejmxsseau (ubuoauitci, 56.6% - 99.7%)
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
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