Stem definition | Drug id | CAS RN |
---|---|---|
HIV protease inhibitors | 4143 | 206361-99-1 |
Dose | Unit | Route |
---|---|---|
1.20 | g | O |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
S (Water solubility) | 0.15 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 1.20 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 20.87 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 37 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
CL (Clearance) | 7.81 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.05 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 15 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
Feb. 12, 2007 | EMA | ||
June 23, 2006 | FDA | JANSSEN PRODS |
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 |
---|---|---|---|---|---|---|
Exposure during pregnancy | 1523.54 | 64.41 | 376 | 1456 | 24843 | 2331410 |
Foetal exposure during pregnancy | 826.98 | 64.41 | 173 | 1659 | 5079 | 2351174 |
Abortion spontaneous | 719.29 | 64.41 | 184 | 1648 | 13261 | 2342992 |
Maternal exposure during pregnancy | 421.83 | 64.41 | 124 | 1708 | 14739 | 2341514 |
Live birth | 311.61 | 64.41 | 61 | 1771 | 1230 | 2355023 |
Premature baby | 309.30 | 64.41 | 71 | 1761 | 3133 | 2353120 |
Premature labour | 298.81 | 64.41 | 64 | 1768 | 2042 | 2354211 |
Premature delivery | 225.46 | 64.41 | 55 | 1777 | 3145 | 2353108 |
Foetal death | 214.76 | 64.41 | 48 | 1784 | 1864 | 2354389 |
Foetal growth restriction | 209.78 | 64.41 | 43 | 1789 | 1097 | 2355156 |
Immune reconstitution inflammatory syndrome | 188.74 | 64.41 | 40 | 1792 | 1204 | 2355049 |
Rash | 178.44 | 64.41 | 98 | 1734 | 59460 | 2296793 |
Lipodystrophy acquired | 148.40 | 64.41 | 26 | 1806 | 273 | 2355980 |
Stillbirth | 139.13 | 64.41 | 32 | 1800 | 1409 | 2354844 |
Hepatocellular injury | 137.24 | 64.41 | 39 | 1793 | 4016 | 2352237 |
Abortion induced | 129.71 | 64.41 | 36 | 1796 | 3400 | 2352853 |
Caesarean section | 128.02 | 64.41 | 37 | 1795 | 4044 | 2352209 |
Congenital naevus | 123.94 | 64.41 | 17 | 1815 | 23 | 2356230 |
Treatment noncompliance | 121.08 | 64.41 | 38 | 1794 | 5496 | 2350757 |
Spina bifida | 116.99 | 64.41 | 19 | 1813 | 120 | 2356133 |
Drug interaction | 115.39 | 64.41 | 58 | 1774 | 29105 | 2327148 |
Viral mutation identified | 112.06 | 64.41 | 20 | 1812 | 235 | 2356018 |
Sudden infant death syndrome | 110.74 | 64.41 | 17 | 1815 | 70 | 2356183 |
Acoustic stimulation tests abnormal | 107.11 | 64.41 | 15 | 1817 | 26 | 2356227 |
Low set ears | 105.84 | 64.41 | 16 | 1816 | 58 | 2356195 |
Premature rupture of membranes | 103.01 | 64.41 | 23 | 1809 | 883 | 2355370 |
Supernumerary nipple | 101.66 | 64.41 | 13 | 1819 | 5 | 2356248 |
Drug resistance | 101.33 | 64.41 | 28 | 1804 | 2596 | 2353657 |
Anal atresia | 96.53 | 64.41 | 15 | 1817 | 68 | 2356185 |
Rash maculo-papular | 96.32 | 64.41 | 30 | 1802 | 4222 | 2352031 |
Cloacal exstrophy | 94.29 | 64.41 | 12 | 1820 | 4 | 2356249 |
Viral load increased | 91.70 | 64.41 | 17 | 1815 | 250 | 2356003 |
Congenital heart valve disorder | 90.04 | 64.41 | 13 | 1819 | 31 | 2356222 |
Eosinophilia | 88.99 | 64.41 | 26 | 1806 | 2944 | 2353309 |
Bladder agenesis | 87.75 | 64.41 | 11 | 1821 | 2 | 2356251 |
Congenital pulmonary valve disorder | 86.35 | 64.41 | 12 | 1820 | 19 | 2356234 |
Congenital genital malformation | 84.17 | 64.41 | 11 | 1821 | 7 | 2356246 |
Cholestasis of pregnancy | 83.40 | 64.41 | 14 | 1818 | 111 | 2356142 |
Oligohydramnios | 80.36 | 64.41 | 19 | 1813 | 941 | 2355312 |
Genitalia external ambiguous | 80.13 | 64.41 | 11 | 1821 | 15 | 2356238 |
Cerebral ventricle dilatation | 76.76 | 64.41 | 14 | 1818 | 187 | 2356066 |
Gastrointestinal disorder congenital | 76.74 | 64.41 | 10 | 1822 | 6 | 2356247 |
Ventricular hypertrophy | 76.46 | 64.41 | 17 | 1815 | 639 | 2355614 |
Congenital anomaly | 75.80 | 64.41 | 16 | 1816 | 469 | 2355784 |
Tethered cord syndrome | 75.67 | 64.41 | 11 | 1821 | 28 | 2356225 |
Meningomyelocele | 75.28 | 64.41 | 12 | 1820 | 66 | 2356187 |
Dermatitis exfoliative generalised | 74.89 | 64.41 | 15 | 1817 | 337 | 2355916 |
Cushing's syndrome | 73.33 | 64.41 | 17 | 1815 | 772 | 2355481 |
Meconium stain | 72.94 | 64.41 | 11 | 1821 | 39 | 2356214 |
Maternal drugs affecting foetus | 71.36 | 64.41 | 19 | 1813 | 1528 | 2354725 |
Skull malformation | 70.84 | 64.41 | 12 | 1820 | 101 | 2356152 |
Cardiac murmur | 70.13 | 64.41 | 19 | 1813 | 1632 | 2354621 |
Caudal regression syndrome | 70.13 | 64.41 | 10 | 1822 | 21 | 2356232 |
Exomphalos | 69.89 | 64.41 | 11 | 1821 | 55 | 2356198 |
Neonatal respiratory arrest | 68.92 | 64.41 | 10 | 1822 | 25 | 2356228 |
Anaemia | 68.79 | 64.41 | 44 | 1788 | 34748 | 2321505 |
Pulmonary valve sclerosis | 65.15 | 64.41 | 8 | 1824 | 0 | 2356253 |
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 |
---|---|---|---|---|---|---|
Foetal exposure during pregnancy | 625.78 | 33.10 | 176 | 2952 | 6183 | 1737470 |
Immune reconstitution inflammatory syndrome | 581.95 | 33.10 | 126 | 3002 | 1423 | 1742230 |
Lipodystrophy acquired | 355.35 | 33.10 | 66 | 3062 | 307 | 1743346 |
Progressive external ophthalmoplegia | 260.51 | 33.10 | 39 | 3089 | 21 | 1743632 |
Drug interaction | 252.90 | 33.10 | 136 | 2992 | 27822 | 1715831 |
Diarrhoea | 239.35 | 33.10 | 166 | 2962 | 53686 | 1689967 |
Mitochondrial toxicity | 239.29 | 33.10 | 43 | 3085 | 159 | 1743494 |
Premature baby | 202.62 | 33.10 | 62 | 3066 | 2880 | 1740773 |
Eyelid ptosis | 194.40 | 33.10 | 45 | 3083 | 692 | 1742961 |
Rash | 180.07 | 33.10 | 123 | 3005 | 38570 | 1705083 |
Drug reaction with eosinophilia and systemic symptoms | 169.51 | 33.10 | 62 | 3066 | 5008 | 1738645 |
Acute kidney injury | 155.14 | 33.10 | 108 | 3020 | 34836 | 1708817 |
Viral load increased | 145.21 | 33.10 | 34 | 3094 | 550 | 1743103 |
Nausea | 142.99 | 33.10 | 120 | 3008 | 51076 | 1692577 |
Osteoporosis | 142.92 | 33.10 | 41 | 3087 | 1514 | 1742139 |
Nephrolithiasis | 130.34 | 33.10 | 48 | 3080 | 3944 | 1739709 |
Pyrexia | 125.80 | 33.10 | 107 | 3021 | 46293 | 1697360 |
Diplopia | 122.63 | 33.10 | 41 | 3087 | 2529 | 1741124 |
Virologic failure | 118.86 | 33.10 | 27 | 3101 | 379 | 1743274 |
Renal tubular disorder | 117.08 | 33.10 | 31 | 3097 | 844 | 1742809 |
Renal impairment | 116.64 | 33.10 | 62 | 3066 | 12252 | 1731401 |
Rash maculo-papular | 115.27 | 33.10 | 43 | 3085 | 3660 | 1739993 |
Hypertriglyceridaemia | 111.63 | 33.10 | 32 | 3096 | 1177 | 1742476 |
Drug resistance | 95.03 | 33.10 | 36 | 3092 | 3194 | 1740459 |
Hepatitis | 93.11 | 33.10 | 40 | 3088 | 4915 | 1738738 |
Vomiting | 92.84 | 33.10 | 83 | 3045 | 38232 | 1705421 |
Mycobacterium avium complex infection | 91.00 | 33.10 | 21 | 3107 | 317 | 1743336 |
Thrombocytopenia | 87.76 | 33.10 | 63 | 3065 | 21186 | 1722467 |
Renal failure | 81.84 | 33.10 | 59 | 3069 | 19958 | 1723695 |
Dyslipidaemia | 81.38 | 33.10 | 23 | 3105 | 802 | 1742851 |
Low birth weight baby | 79.73 | 33.10 | 23 | 3105 | 864 | 1742789 |
Osteonecrosis | 77.78 | 33.10 | 33 | 3095 | 3929 | 1739724 |
Hyperlipidaemia | 73.42 | 33.10 | 27 | 3101 | 2202 | 1741451 |
Stevens-Johnson syndrome | 72.73 | 33.10 | 30 | 3098 | 3327 | 1740326 |
Hepatocellular injury | 70.43 | 33.10 | 29 | 3099 | 3202 | 1740451 |
Pruritus | 69.78 | 33.10 | 57 | 3071 | 23165 | 1720488 |
Headache | 68.75 | 33.10 | 67 | 3061 | 34309 | 1709344 |
Blood creatinine increased | 68.41 | 33.10 | 46 | 3082 | 13900 | 1729753 |
Foetal growth restriction | 67.15 | 33.10 | 19 | 3109 | 665 | 1742988 |
Weight increased | 66.83 | 33.10 | 42 | 3086 | 11315 | 1732338 |
Insomnia | 66.54 | 33.10 | 48 | 3080 | 16228 | 1727425 |
Myocardial infarction | 65.94 | 33.10 | 59 | 3069 | 27115 | 1716538 |
Hemivertebra | 64.54 | 33.10 | 11 | 3117 | 27 | 1743626 |
Viral mutation identified | 63.22 | 33.10 | 16 | 3112 | 362 | 1743291 |
Genital herpes simplex | 61.13 | 33.10 | 10 | 3118 | 17 | 1743636 |
Cholestasis | 57.24 | 33.10 | 26 | 3102 | 3639 | 1740014 |
Neuropathy peripheral | 56.39 | 33.10 | 35 | 3093 | 9218 | 1734435 |
Weight decreased | 56.34 | 33.10 | 50 | 3078 | 22703 | 1720950 |
Blood HIV RNULL increased | 56.09 | 33.10 | 13 | 3115 | 200 | 1743453 |
Cushing's syndrome | 55.79 | 33.10 | 16 | 3112 | 588 | 1743065 |
Blood cholesterol increased | 55.40 | 33.10 | 24 | 3104 | 3002 | 1740651 |
Polydactyly | 55.26 | 33.10 | 13 | 3115 | 214 | 1743439 |
Eosinophilia | 55.02 | 33.10 | 25 | 3103 | 3502 | 1740151 |
Liver function test abnormal | 54.58 | 33.10 | 29 | 3099 | 5697 | 1737956 |
Genital herpes | 52.87 | 33.10 | 11 | 3117 | 99 | 1743554 |
Fatigue | 52.03 | 33.10 | 70 | 3058 | 50711 | 1692942 |
Congenital mitral valve incompetence | 51.99 | 33.10 | 9 | 3119 | 25 | 1743628 |
Treatment noncompliance | 51.44 | 33.10 | 27 | 3101 | 5174 | 1738479 |
CD4 lymphocytes decreased | 51.35 | 33.10 | 14 | 3114 | 426 | 1743227 |
HIV-associated neurocognitive disorder | 51.06 | 33.10 | 10 | 3118 | 64 | 1743589 |
Hepatitis cholestatic | 50.99 | 33.10 | 18 | 3110 | 1303 | 1742350 |
Anaemia | 50.74 | 33.10 | 53 | 3075 | 29404 | 1714249 |
Embolism | 50.00 | 33.10 | 17 | 3111 | 1100 | 1742553 |
Hepatitis B | 49.93 | 33.10 | 18 | 3110 | 1385 | 1742268 |
Oesophageal atresia | 49.80 | 33.10 | 10 | 3118 | 74 | 1743579 |
Diabetes mellitus | 49.49 | 33.10 | 29 | 3099 | 6879 | 1736774 |
Liver disorder | 49.40 | 33.10 | 27 | 3101 | 5609 | 1738044 |
Abdominal pain | 48.81 | 33.10 | 45 | 3083 | 21445 | 1722208 |
Cytomegalovirus chorioretinitis | 48.18 | 33.10 | 13 | 3115 | 380 | 1743273 |
Exposure during pregnancy | 47.22 | 33.10 | 21 | 3107 | 2796 | 1740857 |
Syphilis | 47.11 | 33.10 | 10 | 3118 | 100 | 1743553 |
Congenital anomaly | 47.08 | 33.10 | 13 | 3115 | 415 | 1743238 |
Product use complaint | 46.81 | 33.10 | 12 | 3116 | 286 | 1743367 |
Pneumocystis jirovecii pneumonia | 46.67 | 33.10 | 20 | 3108 | 2436 | 1741217 |
Blood triglycerides increased | 45.57 | 33.10 | 20 | 3108 | 2580 | 1741073 |
Hepatic failure | 45.52 | 33.10 | 26 | 3102 | 5877 | 1737776 |
Hypercholesterolaemia | 44.83 | 33.10 | 16 | 3112 | 1196 | 1742457 |
Ophthalmoplegia | 44.41 | 33.10 | 11 | 3117 | 227 | 1743426 |
Spine malformation | 42.69 | 33.10 | 8 | 3120 | 39 | 1743614 |
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma | 42.39 | 33.10 | 7 | 3121 | 13 | 1743640 |
HIV lipodystrophy | 41.71 | 33.10 | 6 | 3122 | 1 | 1743652 |
Proteinuria | 40.72 | 33.10 | 19 | 3109 | 2825 | 1740828 |
Congenital hydronephrosis | 40.38 | 33.10 | 9 | 3119 | 115 | 1743538 |
Malaise | 40.17 | 33.10 | 47 | 3081 | 29518 | 1714135 |
Pancreatitis acute | 39.78 | 33.10 | 21 | 3107 | 4066 | 1739587 |
Jaundice | 39.64 | 33.10 | 24 | 3104 | 6038 | 1737615 |
Superior mesenteric artery syndrome | 39.56 | 33.10 | 7 | 3121 | 23 | 1743630 |
Blood bilirubin increased | 39.11 | 33.10 | 24 | 3104 | 6186 | 1737467 |
Pancytopenia | 38.57 | 33.10 | 30 | 3098 | 11327 | 1732326 |
Anogenital dysplasia | 38.48 | 33.10 | 7 | 3121 | 28 | 1743625 |
Drug-induced liver injury | 38.38 | 33.10 | 19 | 3109 | 3218 | 1740435 |
Amniotic band syndrome | 37.99 | 33.10 | 6 | 3122 | 7 | 1743646 |
Gene mutation | 37.93 | 33.10 | 9 | 3119 | 154 | 1743499 |
Maternal drugs affecting foetus | 37.86 | 33.10 | 14 | 3114 | 1157 | 1742496 |
Hyperglycaemia | 37.82 | 33.10 | 22 | 3106 | 5143 | 1738510 |
Candida infection | 37.38 | 33.10 | 16 | 3112 | 1942 | 1741711 |
Asthenia | 37.28 | 33.10 | 49 | 3079 | 34621 | 1709032 |
Neutropenia | 37.16 | 33.10 | 36 | 3092 | 18224 | 1725429 |
Progressive multifocal leukoencephalopathy | 36.68 | 33.10 | 15 | 3113 | 1624 | 1742029 |
Myalgia | 35.93 | 33.10 | 33 | 3095 | 15625 | 1728028 |
Hospitalisation | 35.62 | 33.10 | 30 | 3098 | 12670 | 1730983 |
Pathogen resistance | 35.14 | 33.10 | 13 | 3115 | 1076 | 1742577 |
Hepatitis C | 34.90 | 33.10 | 17 | 3111 | 2779 | 1740874 |
Glomerular filtration rate decreased | 34.89 | 33.10 | 14 | 3114 | 1443 | 1742210 |
HIV associated nephropathy | 34.84 | 33.10 | 6 | 3122 | 16 | 1743637 |
Extraocular muscle paresis | 34.15 | 33.10 | 7 | 3121 | 58 | 1743595 |
Hepatic function abnormal | 33.83 | 33.10 | 23 | 3105 | 7051 | 1736602 |
Agranulocytosis | 33.75 | 33.10 | 18 | 3110 | 3558 | 1740095 |
Blood creatine phosphokinase increased | 33.60 | 33.10 | 25 | 3103 | 8831 | 1734822 |
Coccidioidomycosis | 33.54 | 33.10 | 8 | 3120 | 140 | 1743513 |
Aspartate aminotransferase increased | 33.48 | 33.10 | 27 | 3101 | 10729 | 1732924 |
Source | Code | Description |
---|---|---|
ATC | J05AE10 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors |
ATC | J05AR14 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
ATC | J05AR22 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
ATC | J05AR26 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
FDA EPC | N0000175889 | Protease Inhibitor |
FDA MoA | N0000190114 | Cytochrome P450 3A Inhibitors |
FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
MeSH PA | D019380 | Anti-HIV Agents |
MeSH PA | D000890 | Anti-Infective Agents |
MeSH PA | D044966 | Anti-Retroviral Agents |
MeSH PA | D000998 | Antiviral Agents |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D017320 | HIV Protease Inhibitors |
MeSH PA | D011480 | Protease Inhibitors |
CHEBI has role | CHEBI:36044 | antiviral drug |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Human immunodeficiency virus infection | indication | 86406008 | DOID:526 |
Coronavirus infection | off-label use | 186747009 | |
Hypercholesterolemia | contraindication | 13644009 | |
Cirrhosis of liver | contraindication | 19943007 | DOID:5082 |
Hereditary factor VIII deficiency disease | contraindication | 28293008 | DOID:12134 |
Hereditary factor IX deficiency disease | contraindication | 41788008 | DOID:12259 |
Hepatic failure | contraindication | 59927004 | |
Chronic type B viral hepatitis | contraindication | 61977001 | |
Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
Hyperglycemia | contraindication | 80394007 | DOID:4195 |
Chronic hepatitis C | contraindication | 128302006 | |
Liver function tests abnormal | contraindication | 166603001 | |
Disease of liver | contraindication | 235856003 | DOID:409 |
Hypertriglyceridemia | contraindication | 302870006 | |
Breastfeeding (mother) | contraindication | 413712001 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 13.67 | acidic |
pKa2 | 1.64 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 6642245 | Nov. 4, 2020 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
800MG | PREZCOBIX | JANSSEN PRODS | N205395 | Jan. 29, 2015 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | July 17, 2020 | NEW COMBINATION |
800MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | Nov. 5, 2020 | NEW CHEMICAL ENTITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Pol polyprotein | Enzyme | INHIBITOR | Ki | 10.85 | CHEMBL | CHEMBL | |||
Gag-Pol polyprotein | Polyprotein | Ki | 9.66 | WOMBAT-PK | |||||
Protease | Enzyme | IC50 | 10.21 | CHEMBL |
ID | Source |
---|---|
D000069454 | MESH_DESCRIPTOR_UI |
4025441 | VUID |
N0000179778 | NUI |
C1435444 | UMLSCUI |
D03656 | KEGG_DRUG |
33O78XF0BW | UNII |
635728-49-3 | SECONDARY_CAS_RN |
424096001 | SNOMEDCT_US |
d05825 | MMSL |
460132 | RXNORM |
4025441 | VANDF |
423888002 | SNOMEDCT_US |
011599 | NDDF |
CHEMBL1323 | ChEMBL_ID |
017 | PDB_CHEM_ID |
DB01264 | DRUGBANK_ID |
CHEBI:367163 | CHEBI |
8305 | INN_ID |
CHEMBL1201127 | ChEMBL_ID |
213039 | PUBCHEM_CID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0672 | TABLET, FILM COATED | 400 mg | ORAL | NDA | 18 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0773 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 18 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5969 | TABLET, FILM COATED | 400 mg | ORAL | NDA | 19 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6369 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 19 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59676-562 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 20 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59676-563 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 20 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59676-564 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 20 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59676-565 | SUSPENSION | 100 mg | ORAL | NDA | 20 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59676-566 | TABLET, FILM COATED | 800 mg | ORAL | NDA | 20 sections |
PREZCOBIX | HUMAN PRESCRIPTION DRUG LABEL | 2 | 59676-575 | TABLET, FILM COATED | 800 mg | ORAL | NDA | 19 sections |
Symtuza | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59676-800 | TABLET, FILM COATED | 800 mg | ORAL | NDA | 20 sections |
PREZISTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-1483 | TABLET, FILM COATED | 800 mg | ORAL | NDA | 20 sections |