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rucaparib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| poly-ADP-ribose polymerase inhibitors | 5203 | 283173-50-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Rucaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair. In vitro studies have shown that rucaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased rucaparib-induced cytotoxicity was observed in tumor cell lines with deficiencies in BRCA1/2 and other DNA repair genes. Rucaparib has been shown to decrease tumor growth in mouse xenograft models of human cancer with or without deficiencies in BRCA.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1.20 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 3.28 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 4.31 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 16.60 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 1 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.106 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 19.275 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 1.977 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 6.442 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 25.610 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 47.180 | % | High | 1 |
| herg | hERG pIC50 | 4.843 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.119 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 4.093 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 30.730 | % | High | 1 |
| kinase-safety-class | AAK1,ABL2,ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AURKB,AURKC,AXL,BLK,BMX,BRAF,BTK,CAMK1,CAMK2A,CAMK2B,CAMK2D,CAMK2G,CDK1,CDK14,CDK16,CDK19,CDK2,CDK3,CDK4,CDK5,CDK6,CDK7,CDK9,CHEK1,CHEK2,CHUK,CLK2,CLK4,CSF1R,CSK,DDR1,DYRK1A,DYRK1B,DYRK2,EGFR,EIF2AK3,EPHA2,EPHB1,EPHB4,ERBB2,FGFR1,FLT1,FLT3,FLT4,FYN,GAK,GRK1,GRK2,GSK3A,GSK3B,HASPIN,HIPK2,IGF1R,IKBKB,INSR,IRAK1,IRAK3,IRAK4,ITK,JAK1,JAK2,JAK3,KDR,KIT,LCK,LRRK2,LYN,MAP2K1,MAP2K6,MAP3K1,MAP3K10,MAP3K11,MAP3K14,MAP3K19,MAP3K2,MAP3K21,MAP3K3,MAP3K7,MAP3K9,MAP4K1,MAP4K2,MAP4K3,MAP4K5,MAPK1,MAPK10,MAPK15,MAPK7,MAPK8,MAPK9,MARK1,MARK2,MARK3,MARK4,MELK,MET,MINK1,MKNK2,MST1R,MTOR,NTRK1,NTRK2,NTRK3,NUAK1,PAK1,PAK2,PAK4,PAK5,PDGFRB,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM1,PIM2,PIM3,PLK4,PRKAA1,PRKAA2,PRKACA,PRKCA,PRKCD,PRKCZ,PRKD1,PRKDC,PTK2,RET,ROCK1,ROCK2,RPS6KA1,SGK1,SIK2,SIK3,SRC,STK10,STK16,STK17A,STK3,STK33,STK4,SYK,TBK1,TEK,TGFBR1,TNIK,TNK1,TTK,TYRO3,UHMK1,ULK1,ULK2,YES1,ZAP70 | 165 | |||
| kinase-selectivity-class | AAK1,ACVR2A,ACVR2B,AKT2,ALK,AURKA,AURKB,AURKC,AXL,BLK,BRAF,CAMK2A,CAMK2B,CAMK2D,CDK1,CDK16,CDK2,CDK3,CDK4,CDK6,CDK7,CDK9,CHEK1,CLK2,CLK4,CSF1R,CSK,DDR1,DYRK1A,DYRK1B,DYRK3,EGFR,EIF2AK3,EPHA2,EPHB4,ERBB2,FGFR1,FLT3,FLT4,FYN,GAK,GSK3A,GSK3B,HIPK2,IGF1R,INSR,IRAK1,IRAK3,IRAK4,JAK1,JAK2,KDR,LCK,LRRK2,MAP2K6,MAP3K10,MAP3K11,MAP3K21,MAP3K7,MAP3K9,MAP4K1,MAP4K3,MAP4K5,MAPK1,MAPK12,MAPK7,MARK1,MARK2,MARK3,MARK4,MELK,MET,MINK1,MST1R,NTRK1,NTRK3,NUAK1,PAK4,PDGFRB,PDK1,PDPK1,PIM3,PRKAA1,PRKAA2,PRKACA,PRKCD,PRKCZ,PTK2,RET,ROCK1,ROCK2,SGK1,SIK2,SIK3,SRC,STK10,STK16,STK17A,STK33,STK4,SYK,TEK,TNIK,TTK,TYRO3,ULK1,ULK2,YES1 | 108 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 12.246 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 11.482 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 20.512 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 23.820 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 14.962 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 49.770 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.028 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 11.588 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 61.420 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 34.110 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 704.693 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 24, 2018 | EMA | Clovis Oncology UK Limited | |
| Dec. 19, 2016 | FDA | Clovis Oncology, Inc. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 1792.62 | 35.53 | 734 | 20205 | 106136 | 90501372 |
| Carbohydrate antigen 125 increased | 1607.05 | 35.53 | 318 | 20621 | 2948 | 90604560 |
| Fatigue | 1395.22 | 35.53 | 1500 | 19439 | 1152523 | 89454985 |
| Nausea | 1297.98 | 35.53 | 1419 | 19520 | 1108897 | 89498611 |
| Dysgeusia | 964.69 | 35.53 | 386 | 20553 | 52174 | 90555334 |
| Product dose omission issue | 777.25 | 35.53 | 596 | 20343 | 291091 | 90316417 |
| Tumour marker increased | 554.66 | 35.53 | 149 | 20790 | 5658 | 90601850 |
| Constipation | 463.38 | 35.53 | 436 | 20503 | 279959 | 90327549 |
| Adverse event | 409.30 | 35.53 | 283 | 20656 | 117135 | 90490373 |
| Decreased appetite | 408.26 | 35.53 | 467 | 20472 | 376073 | 90231435 |
| Platelet count decreased | 403.61 | 35.53 | 298 | 20641 | 136671 | 90470837 |
| Underdose | 316.22 | 35.53 | 181 | 20758 | 53836 | 90553672 |
| Accidental underdose | 307.40 | 35.53 | 67 | 20872 | 1024 | 90606484 |
| Ovarian cancer recurrent | 282.28 | 35.53 | 67 | 20872 | 1523 | 90605985 |
| Full blood count abnormal | 256.21 | 35.53 | 138 | 20801 | 36459 | 90571049 |
| Photosensitivity reaction | 223.41 | 35.53 | 100 | 20839 | 17707 | 90589801 |
| Taste disorder | 213.35 | 35.53 | 148 | 20791 | 61398 | 90546110 |
| Red blood cell count decreased | 208.09 | 35.53 | 131 | 20808 | 46220 | 90561288 |
| Anaemia | 197.75 | 35.53 | 318 | 20621 | 352484 | 90255024 |
| Blood creatinine increased | 173.23 | 35.53 | 161 | 20778 | 101225 | 90506283 |
| Sunburn | 164.68 | 35.53 | 51 | 20888 | 3216 | 90604292 |
| Haemoglobin decreased | 163.27 | 35.53 | 194 | 20745 | 161762 | 90445746 |
| Asthenia | 161.32 | 35.53 | 370 | 20569 | 533381 | 90074127 |
| Vomiting | 160.67 | 35.53 | 471 | 20468 | 787822 | 89819686 |
| Renal function test abnormal | 142.72 | 35.53 | 56 | 20883 | 7135 | 90600373 |
| Prescribed underdose | 133.67 | 35.53 | 122 | 20817 | 74897 | 90532611 |
| Condition aggravated | 119.87 | 35.53 | 4 | 20935 | 595541 | 90011967 |
| White blood cell count decreased | 112.19 | 35.53 | 164 | 20775 | 166945 | 90440563 |
| Blood magnesium decreased | 112.08 | 35.53 | 60 | 20879 | 15633 | 90591875 |
| Drug ineffective | 102.41 | 35.53 | 102 | 20837 | 1384196 | 89223312 |
| Abdominal pain | 95.55 | 35.53 | 252 | 20687 | 395469 | 90212039 |
| Abdominal distension | 94.71 | 35.53 | 133 | 20806 | 130468 | 90477040 |
| Neuropathy peripheral | 94.20 | 35.53 | 136 | 20803 | 136834 | 90470674 |
| Diarrhoea | 89.24 | 35.53 | 440 | 20499 | 938750 | 89668758 |
| Flatulence | 89.17 | 35.53 | 75 | 20864 | 41292 | 90566216 |
| Therapy partial responder | 88.25 | 35.53 | 58 | 20881 | 21985 | 90585523 |
| Abdominal pain upper | 84.51 | 35.53 | 216 | 20723 | 332458 | 90275050 |
| Laboratory test abnormal | 84.33 | 35.53 | 73 | 20866 | 41781 | 90565727 |
| Drug hypersensitivity | 84.07 | 35.53 | 6 | 20933 | 463603 | 90143905 |
| Intentional underdose | 78.64 | 35.53 | 26 | 20913 | 2023 | 90605485 |
| Liver function test increased | 63.85 | 35.53 | 88 | 20851 | 84767 | 90522741 |
| Swelling | 62.07 | 35.53 | 11 | 20928 | 419047 | 90188461 |
| Arthropathy | 55.59 | 35.53 | 9 | 20930 | 366233 | 90241275 |
| Early satiety | 54.59 | 35.53 | 18 | 20921 | 1389 | 90606119 |
| General physical health deterioration | 53.28 | 35.53 | 9 | 20930 | 355106 | 90252402 |
| Joint swelling | 53.05 | 35.53 | 25 | 20914 | 503275 | 90104233 |
| Dehydration | 52.17 | 35.53 | 129 | 20810 | 194318 | 90413190 |
| Intestinal obstruction | 50.33 | 35.53 | 52 | 20887 | 37079 | 90570429 |
| Drug interaction | 48.88 | 35.53 | 4 | 20935 | 276449 | 90331059 |
| Discomfort | 48.42 | 35.53 | 4 | 20935 | 274331 | 90333177 |
| Lower respiratory tract infection | 46.10 | 35.53 | 3 | 20936 | 250656 | 90356852 |
| Pneumonia | 44.68 | 35.53 | 49 | 20890 | 638010 | 89969498 |
| Glossodynia | 44.38 | 35.53 | 10 | 20929 | 321769 | 90285739 |
| Wheezing | 43.35 | 35.53 | 3 | 20936 | 238077 | 90369431 |
| Small intestinal obstruction | 42.69 | 35.53 | 37 | 20902 | 21197 | 90586311 |
| Confusional state | 42.54 | 35.53 | 18 | 20921 | 386187 | 90221321 |
| Urticaria | 40.64 | 35.53 | 11 | 20928 | 312723 | 90294785 |
| Mobility decreased | 38.39 | 35.53 | 6 | 20933 | 250728 | 90356780 |
| Thrombocytopenia | 36.83 | 35.53 | 119 | 20820 | 208606 | 90398902 |
| Asthma | 36.61 | 35.53 | 6 | 20933 | 242154 | 90365354 |
| Aspartate aminotransferase increased | 36.14 | 35.53 | 76 | 20863 | 102861 | 90504647 |
| Type 2 diabetes mellitus | 35.75 | 35.53 | 3 | 20936 | 203241 | 90404267 |
| Musculoskeletal stiffness | 35.68 | 35.53 | 12 | 20927 | 296520 | 90310988 |
| Hypertension | 35.60 | 35.53 | 32 | 20907 | 457500 | 90150008 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 56.10 | 39.02 | 26 | 441 | 108374 | 42512494 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Fatigue | 972.22 | 34.79 | 932 | 12241 | 1215026 | 109361100 |
| Carbohydrate antigen 125 increased | 970.96 | 34.79 | 180 | 12993 | 2367 | 110573759 |
| Nausea | 814.23 | 34.79 | 854 | 12319 | 1234836 | 109341290 |
| Dysgeusia | 634.81 | 34.79 | 257 | 12916 | 69728 | 110506398 |
| Malignant neoplasm progression | 516.46 | 34.79 | 297 | 12876 | 174270 | 110401856 |
| Product dose omission issue | 477.37 | 34.79 | 355 | 12818 | 321427 | 110254699 |
| Tumour marker increased | 437.84 | 34.79 | 105 | 13068 | 4955 | 110571171 |
| Constipation | 314.95 | 34.79 | 292 | 12881 | 357494 | 110218632 |
| Decreased appetite | 277.59 | 34.79 | 311 | 12862 | 475535 | 110100591 |
| Underdose | 253.49 | 34.79 | 132 | 13041 | 63422 | 110512704 |
| Accidental underdose | 250.52 | 34.79 | 52 | 13121 | 1253 | 110574873 |
| Platelet count decreased | 177.46 | 34.79 | 175 | 12998 | 230268 | 110345858 |
| Prescribed underdose | 153.49 | 34.79 | 96 | 13077 | 65078 | 110511048 |
| Ovarian cancer recurrent | 148.13 | 34.79 | 30 | 13143 | 637 | 110575489 |
| Adverse event | 134.29 | 34.79 | 108 | 13065 | 108701 | 110467425 |
| Red blood cell count decreased | 130.33 | 34.79 | 87 | 13086 | 65836 | 110510290 |
| Vomiting | 129.84 | 34.79 | 314 | 12859 | 910361 | 109665765 |
| Taste disorder | 121.40 | 34.79 | 83 | 13090 | 65304 | 110510822 |
| Full blood count abnormal | 120.60 | 34.79 | 78 | 13095 | 55974 | 110520152 |
| Anaemia | 117.46 | 34.79 | 223 | 12950 | 546863 | 110029263 |
| Photosensitivity reaction | 116.03 | 34.79 | 58 | 13115 | 25531 | 110550595 |
| Sunburn | 107.32 | 34.79 | 34 | 13139 | 4514 | 110571612 |
| Asthenia | 101.65 | 34.79 | 241 | 12932 | 688758 | 109887368 |
| Haemoglobin decreased | 96.75 | 34.79 | 133 | 13040 | 248594 | 110327532 |
| Renal function test abnormal | 91.83 | 34.79 | 36 | 13137 | 8910 | 110567216 |
| Blood magnesium decreased | 86.77 | 34.79 | 44 | 13129 | 19952 | 110556174 |
| Diarrhoea | 79.60 | 34.79 | 306 | 12867 | 1139199 | 109436927 |
| Abdominal pain upper | 71.90 | 34.79 | 140 | 13033 | 348971 | 110227155 |
| Abdominal pain | 70.73 | 34.79 | 175 | 12998 | 512814 | 110063312 |
| Condition aggravated | 68.48 | 34.79 | 5 | 13168 | 734831 | 109841295 |
| White blood cell count decreased | 63.90 | 34.79 | 105 | 13068 | 229285 | 110346841 |
| Blood creatinine increased | 61.06 | 34.79 | 91 | 13082 | 182798 | 110393328 |
| Liver function test increased | 54.95 | 34.79 | 60 | 13113 | 88488 | 110487638 |
| Flatulence | 54.39 | 34.79 | 47 | 13126 | 52102 | 110524024 |
| Abdominal distension | 54.03 | 34.79 | 84 | 13089 | 175019 | 110401107 |
| Intentional underdose | 51.72 | 34.79 | 17 | 13156 | 2535 | 110573591 |
| Neuropathy peripheral | 49.82 | 34.79 | 82 | 13091 | 179195 | 110396931 |
| Drug interaction | 47.74 | 34.79 | 3 | 13170 | 500180 | 110075946 |
| Drug ineffective | 46.02 | 34.79 | 69 | 13104 | 1520471 | 109055655 |
| Drug hypersensitivity | 42.51 | 34.79 | 3 | 13170 | 454087 | 110122039 |
| Dehydration | 42.34 | 34.79 | 99 | 13074 | 279412 | 110296714 |
| Laboratory test abnormal | 40.54 | 34.79 | 37 | 13136 | 44042 | 110532084 |
| Intestinal obstruction | 40.06 | 34.79 | 40 | 13133 | 53187 | 110522939 |
| Abdominal discomfort | 39.82 | 34.79 | 120 | 13053 | 393738 | 110182388 |
| Small intestinal obstruction | 39.74 | 34.79 | 32 | 13141 | 32181 | 110543945 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XK03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Poly (ADP-ribose) polymerase (PARP) inhibitors |
| MeSH PA | D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA MoA | N0000191622 | Poly(ADP-Ribose) Polymerase Inhibitors |
| FDA EPC | N0000191623 | Poly(ADP-Ribose) Polymerase Inhibitor |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:62913 | EC 2.4.2.30 (NAD<small><sup>+</small></sup> ADP-ribosyltransferase) inhibitor |
Related Drugs by ATC class:
L01XK Poly (ADP-ribose) polymerase (PARP) inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Malignant tumor of ovary | indication | 363443007 | DOID:2394 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.08 | acidic |
| pKa2 | 13.73 | acidic |
| pKa3 | 9.45 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 9861638 | Feb. 10, 2031 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 9861638 | Feb. 10, 2031 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 9861638 | Feb. 10, 2031 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 9861638 | Feb. 10, 2031 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 9861638 | Feb. 10, 2031 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 9861638 | Feb. 10, 2031 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | 10130636 | Aug. 17, 2035 | MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | Dec. 17, 2028 | EXPANSION TO THE TREATMENT OF ADULT PATIENTS WITH A DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC)-ASSOCIATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) INDICATION |
| EQ 250MG BASE | RUBRACA | PHARMAAND | N209115 | May 1, 2017 | RX | TABLET | ORAL | Dec. 17, 2028 | EXPANSION TO THE TREATMENT OF ADULT PATIENTS WITH A DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC)-ASSOCIATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) INDICATION |
| EQ 300MG BASE | RUBRACA | PHARMAAND | N209115 | Dec. 19, 2016 | RX | TABLET | ORAL | Dec. 17, 2028 | EXPANSION TO THE TREATMENT OF ADULT PATIENTS WITH A DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC)-ASSOCIATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) INDICATION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Poly [ADP-ribose] polymerase 2 | Enzyme | INHIBITOR | IC50 | 7.55 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Poly [ADP-ribose] polymerase 1 | Enzyme | INHIBITOR | IC50 | 8.50 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Poly [ADP-ribose] polymerase 3 | Enzyme | INHIBITOR | IC50 | 6.39 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Serine/threonine-protein kinase pim-3 | Kinase | IC50 | 6.36 | CHEMBL | |||||
| Dual specificity tyrosine-phosphorylation-regulated kinase 1A | Kinase | IC50 | 5.63 | CHEMBL | |||||
| Mono [ADP-ribose] polymerase PARP16 | Enzyme | Kd | 5.54 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 9 | Enzyme | Kd | 5.51 | CHEMBL | |||||
| Tankyrase-2 | Enzyme | INHIBITOR | IC50 | 6.05 | SCIENTIFIC LITERATURE | ||||
| DNA polymerase alpha catalytic subunit | Enzyme | IC50 | 9.40 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 4 | Enzyme | INHIBITOR | IC50 | 6.08 | SCIENTIFIC LITERATURE | ||||
| Poly [ADP-ribose] polymerase 10 | Enzyme | INHIBITOR | IC50 | 6.25 | SCIENTIFIC LITERATURE | ||||
| Poly [ADP-ribose] polymerase 12 | Enzyme | INHIBITOR | IC50 | 5.18 | SCIENTIFIC LITERATURE | ||||
| Poly [ADP-ribose] polymerase 14 | Enzyme | INHIBITOR | IC50 | 5.05 | SCIENTIFIC LITERATURE | ||||
| Poly [ADP-ribose] polymerase 15 | Enzyme | INHIBITOR | IC50 | 4.49 | SCIENTIFIC LITERATURE | ||||
| Tankyrase-1 | Enzyme | INHIBITOR | IC50 | 6.84 | SCIENTIFIC LITERATURE | ||||
| Cyclin-dependent kinase 16 | Kinase | IC50 | 6.42 | CHEMBL | |||||
| Dual specificity tyrosine-phosphorylation-regulated kinase 1B | Kinase | IC50 | 6.13 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 8237F3U7EH | UNII |
| 1859053-21-6 | SECONDARY_CAS_RN |
| 459868-92-9 | SECONDARY_CAS_RN |
| 4036311 | VANDF |
| C3661315 | UMLSCUI |
| CHEBI:134689 | CHEBI |
| RPB | PDB_CHEM_ID |
| CHEMBL1173055 | ChEMBL_ID |
| 9931954 | PUBCHEM_CID |
| DB12332 | DRUGBANK_ID |
| D10079 | KEGG_DRUG |
| CHEMBL3833368 | ChEMBL_ID |
| CHEMBL2105733 | ChEMBL_ID |
| 9471 | INN_ID |
| C531549 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7736 | IUPHAR_LIGAND_ID |
| C520469 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1217204001 | SNOMEDCT_US |
| 723984009 | SNOMEDCT_US |
| 763539004 | SNOMEDCT_US |
| 247942 | MMSL |
| 32185 | MMSL |
| d08507 | MMSL |
| 017056 | NDDF |
| 017057 | NDDF |
| 1862578 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Rubraca | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82154-0783 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 30 sections |
| Rubraca | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82154-0784 | TABLET, FILM COATED | 250 mg | ORAL | NDA | 30 sections |
| Rubraca | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82154-0785 | TABLET, FILM COATED | 300 mg | ORAL | NDA | 30 sections |