rucaparib Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
poly-ADP-ribose polymerase inhibitors 5203 283173-50-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rucaparib
  • rucaparib camsylate
  • AG-14447
  • rucaparib phosphate
  • AG-14699
  • AG014699
  • PF01367338
  • PF-1367338-BW
  • CO-338
  • rubraca
  • rucaparib camphorsulfonate
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.
  • Molecular weight: 323.37
  • Formula: C19H18FN3O
  • CLOGP: 3.01
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 56.92
  • ALOGS: -4.45
  • ROTB: 3

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
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

Approvals:

DateAgencyCompanyOrphan
May 24, 2018 EMA Clovis Oncology UK Limited
Dec. 19, 2016 FDA Clovis Oncology, Inc.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Fatigue 3938.08 69.67 1124 1988 83749 2271224
Nausea 3385.02 69.67 1069 2043 111120 2243853
Malignant neoplasm progression 2317.60 69.67 511 2601 11617 2343356
Dysgeusia 1560.07 69.67 348 2764 8111 2346862
Carbohydrate antigen 125 increased 1437.57 69.67 212 2900 292 2354681
Product dose omission 1341.93 69.67 421 2691 37836 2317137
Decreased appetite 1244.66 69.67 373 2739 28518 2326455
Constipation 1135.11 69.67 326 2786 21303 2333670
Vomiting 906.04 69.67 371 2741 71231 2283742
Underdose 748.11 69.67 181 2931 5897 2349076
Diarrhoea 707.79 69.67 327 2785 83237 2271736
Platelet count decreased 683.49 69.67 206 2906 15607 2339366
Asthenia 619.32 69.67 252 2860 46674 2308299
Tumour marker increased 615.66 69.67 108 3004 636 2354337
Anaemia 599.91 69.67 227 2885 34565 2320408
Taste disorder 586.58 69.67 96 3016 342 2354631
Prescribed underdose 586.47 69.67 122 2990 1940 2353033
Adverse event 533.26 69.67 145 2967 7514 2347459
Abdominal pain 442.78 69.67 182 2930 34192 2320781
Haemoglobin decreased 425.34 69.67 149 2963 18002 2336971
Abdominal pain upper 418.78 69.67 155 2957 21945 2333028
Red blood cell count decreased 398.02 69.67 102 3010 4164 2350809
Blood count abnormal 395.80 69.67 90 3022 2192 2352781
Blood creatinine increased 347.50 69.67 112 3000 10421 2344552
Photosensitivity reaction 321.80 69.67 77 3035 2350 2352623
Accidental underdose 303.02 69.67 50 3062 188 2354785
White blood cell count decreased 298.25 69.67 115 2997 18093 2336880
Dyspnoea 291.81 69.67 179 2933 78554 2276419
Dizziness 284.74 69.67 159 2953 58506 2296467
Malaise 281.62 69.67 155 2957 55430 2299543
Weight decreased 277.64 69.67 124 2988 28247 2326726
Abdominal discomfort 274.26 69.67 107 3005 17349 2337624
Liver function test increased 268.80 69.67 70 3042 3031 2351942
Abdominal distension 264.53 69.67 91 3021 10320 2344653
Off label use 238.74 69.67 154 2958 73444 2281529
Neuropathy peripheral 237.30 69.67 86 3026 11346 2343627
Dyspepsia 234.39 69.67 82 3030 9762 2345211
Pruritus 224.94 69.67 123 2989 43217 2311756
Insomnia 218.30 69.67 102 3010 25685 2329288
Headache 212.41 69.67 148 2964 80031 2274942
Hepatic enzyme increased 208.07 69.67 75 3037 9727 2345246
Renal function test abnormal 192.18 69.67 38 3074 455 2354518
Thrombocytopenia 187.94 69.67 84 3028 19047 2335926
Sunburn 186.87 69.67 38 3074 529 2354444
Drug intolerance 176.73 69.67 73 3039 13644 2341329
Dehydration 172.60 69.67 83 3029 22212 2332761
Flatulence 168.99 69.67 53 3059 4472 2350501
Blood magnesium decreased 165.34 69.67 40 3072 1272 2353701
Peripheral swelling 137.55 69.67 66 3046 17531 2337442
Dry mouth 130.68 69.67 51 3061 8202 2346771
Pain 128.76 69.67 99 3013 61758 2293215
Therapy partial responder 127.21 69.67 26 3086 371 2354602
Intentional underdose 125.81 69.67 26 3086 393 2354580
Ovarian cancer recurrent 122.95 69.67 23 3089 200 2354773
Alanine aminotransferase increased 119.94 69.67 56 3056 13976 2340997
Cough 115.84 69.67 73 3039 33044 2321929
Stomatitis 112.61 69.67 48 3064 9662 2345311
Laboratory test abnormal 110.29 69.67 40 3072 5250 2349723
Intestinal obstruction 105.90 69.67 37 3075 4356 2350617
Aspartate aminotransferase increased 103.64 69.67 49 3063 12563 2342410
Feeling abnormal 103.06 69.67 60 3052 23521 2331452
Rash 97.66 69.67 83 3029 59475 2295498
Somnolence 95.39 69.67 57 3055 23428 2331545
Dry skin 94.40 69.67 38 3074 6614 2348359
Back pain 93.99 69.67 63 3049 31596 2323377
Alopecia 93.53 69.67 55 3057 21946 2333027
Anxiety 93.39 69.67 61 3051 29298 2325675
Nasopharyngitis 90.78 69.67 54 3058 22002 2332971
Adverse drug reaction 89.61 69.67 39 3073 8244 2346729
Death 88.06 69.67 90 3022 81378 2273595
Hot flush 84.79 69.67 36 3076 7163 2347810
Early satiety 84.24 69.67 16 3096 152 2354821
Product use in unapproved indication 81.35 69.67 40 3072 11160 2343813
Arthralgia 77.54 69.67 70 3042 54215 2300758
Therapy cessation 74.82 69.67 30 3082 5163 2349810
Renal impairment 73.15 69.67 36 3076 10056 2344917
Bone marrow failure 72.18 69.67 30 3082 5656 2349317
Unevaluable event 71.33 69.67 34 3078 8857 2346116

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Off label use 58.19 40.19 17 47 38554 1708163
Product use in unapproved indication 42.32 40.19 10 54 9412 1737305

Pharmacologic Action:

SourceCodeDescription
ATC L01XX55 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Other antineoplastic agents
FDA EPC N0000191623 Poly(ADP-Ribose) Polymerase Inhibitor
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D000067856 Poly(ADP-ribose) Polymerase Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Malignant tumor of ovary indication 363443007 DOID:2394

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.08 acidic
pKa2 13.73 acidic
pKa3 9.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7351701 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7351701 July 23, 2024 A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7351701 July 23, 2024 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 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7531530 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7531530 July 23, 2024 A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7531530 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 7351701 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 7351701 July 23, 2024 A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
EQ 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 7351701 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 7531530 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 7531530 July 23, 2024 A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
EQ 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 7531530 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7351701 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7351701 July 23, 2024 A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
EQ 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7351701 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7531530 July 23, 2024 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7531530 July 23, 2024 A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
EQ 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 7531530 July 23, 2024 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 200MG BASE RUBRACA CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 8071579 Aug. 12, 2027 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 200MG BASE RUBRACA CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 8143241 Aug. 12, 2027 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 8071579 Aug. 12, 2027 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 8143241 Aug. 12, 2027 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 8071579 Aug. 12, 2027 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 8143241 Aug. 12, 2027 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 200MG BASE RUBRACA CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 9861638 Feb. 10, 2031 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 9861638 Feb. 10, 2031 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 9861638 Feb. 10, 2031 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 200MG BASE RUBRACA CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 8859562 Aug. 4, 2031 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL 8859562 Aug. 4, 2031 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL 8859562 Aug. 4, 2031 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 200MG BASE RUBRACA CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 CLOVIS ONCOLOGY INC 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL April 6, 2021 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL April 6, 2021 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL April 6, 2021 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL Dec. 19, 2021 NEW CHEMICAL ENTITY
EQ 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL Dec. 19, 2021 NEW CHEMICAL ENTITY
EQ 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL Dec. 19, 2021 NEW CHEMICAL ENTITY
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL Dec. 19, 2023 AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
EQ 250MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL Dec. 19, 2023 AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
EQ 300MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL Dec. 19, 2023 AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
EQ 200MG BASE RUBRACA CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL April 6, 2025 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH 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 CLOVIS ONCOLOGY INC N209115 May 1, 2017 RX TABLET ORAL April 6, 2025 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH 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 CLOVIS ONCOLOGY INC N209115 Dec. 19, 2016 RX TABLET ORAL April 6, 2025 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Poly [ADP-ribose] polymerase 1 Enzyme INHIBITOR IC50 8.50 SCIENTIFIC LITERATURE DRUG LABEL
Poly [ADP-ribose] polymerase 2 Enzyme INHIBITOR IC50 7.55 SCIENTIFIC LITERATURE DRUG LABEL
Poly [ADP-ribose] polymerase 3 Enzyme INHIBITOR IC50 6.39 SCIENTIFIC LITERATURE DRUG LABEL
Poly [ADP-ribose] polymerase 4 Enzyme INHIBITOR IC50 6.08 SCIENTIFIC LITERATURE
Tankyrase-1 Enzyme INHIBITOR IC50 6.84 SCIENTIFIC LITERATURE
Tankyrase-2 Enzyme INHIBITOR IC50 6.05 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

External reference:

IDSource
41AX9SJ8KO UNII
1859053-21-6 SECONDARY_CAS_RN
763539004 SNOMEDCT_US
1862579 RXNORM
017056 NDDF
4036311 VANDF
d08507 MMSL
723984009 SNOMEDCT_US
9471 INN_ID
9931954 PUBCHEM_CID
CHEBI:134692 CHEBI
CHEMBL1173055 ChEMBL_ID
D10079 KEGG_DRUG
RPB PDB_CHEM_ID
DB12332 DRUGBANK_ID
CHEMBL2105733 ChEMBL_ID
CHEMBL3833368 ChEMBL_ID
7736 IUPHAR_LIGAND_ID
C531549 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Rubraca HUMAN PRESCRIPTION DRUG LABEL 1 69660-201 TABLET, FILM COATED 200 mg ORAL NDA 18 sections
Rubraca HUMAN PRESCRIPTION DRUG LABEL 1 69660-202 TABLET, FILM COATED 250 mg ORAL NDA 18 sections
Rubraca HUMAN PRESCRIPTION DRUG LABEL 1 69660-203 TABLET, FILM COATED 300 mg ORAL NDA 18 sections