Drug ID:Drug198
Drug Name:Bictegravir
CID:90311989
DrugBank ID:DB11799
Modality:Small Molecule
Groups:NULL
US Approved:YES
Other Approved:YES
Identifier: NCT04518228, , NCT05502341, , NCT06333808, , NCT06629480, , NCT05979311, , NCT04805944, , NCT03711253, , NCT03499483, , NCT02275065, , NCT02400307
Molecular Formula:C21H18F3N3O5
Molecular Weight:449.4 g/mol
Isomeric SMILES:C1C[C@@H]2C[C@H]1N3[C@H](O2)CN4C=C(C(=O)C(=C4C3=O)O)C(=O)NCC5=C(C=C(C=C5F)F)F
Synonyms:Bictegravir; 1611493-60-7; GS-9883; Bictegravir [INN]; GS-9883-01; bictegravirum; Bictegravir [USAN:INN]; (2R,5S,13aR)-8-hydroxy-7,9-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide; 8GB79LOJ07; BICTEGRAVIR [MI]
Phase 0: 0
Phase 1: 13
Phase 2: 19
Phase 3: 33
Phase 4: 41
Description:NULL

Molecular Structure

2D Molecular Structure

Knowledge Graph

dtIDCIDCompound NameGene IDGene NameSpeciesPubMed IDsAction
dt1393 90311989 Bictegravir 1576 CYP3A4 Homo sapiens (human) Substrate
dt1394 90311989 Bictegravir 54658 UGT1A1 Homo sapiens (human) Substrate
dt1395 90311989 Bictegravir 5452 POU2F2 Homo sapiens (human) Inhibitor
dt1396 90311989 Bictegravir 55244 SLC47A1 Homo sapiens (human) Inhibitor
dt1397 90311989 Bictegravir None -- Severe acute respiratory syndrome coronavirus 2 34798775 None
dt1398 90311989 Bictegravir None -- Human immunodeficiency virus 1 Human immunodeficiency virus type 1 integrase inhibitor
dt1399 90311989 Bictegravir 8854 ALDH1A2 Mus musculus (house mouse) 34515794 Bictegravir results in decreased expression of ALDH1A2 mRNA
dt1400 90311989 Bictegravir 1592 CYP26A1 Mus musculus (house mouse) 34515794 Bictegravir results in increased expression of CYP26A1 mRNA
dt1401 90311989 Bictegravir 83881 MIXL1 Mus musculus (house mouse) 34515794 Bictegravir results in increased expression of MIXL1 mRNA
dt1402 90311989 Bictegravir 2253 FGF8 Mus musculus (house mouse) 34515794 Bictegravir results in increased expression of FGF8 mRNA

  • No data available

Phase Distribution
Phase Description
  • Phase 0: Exploratory trials to assess drug behavior in humans
  • Phase 1: Safety trials to determine safe dosage range
  • Phase 2: Efficacy trials to evaluate therapeutic effects
  • Phase 3: Large-scale trials to confirm efficacy and safety
  • Phase 4: Post-marketing surveillance for long-term safety and efficacy

Trial IDTitlePhaseStatusSponsorIndicationsInterventions
NCT05575505 Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis. PHASE2 RECRUITING Tanta University Inflammatory Bowel Diseases DRUG: Pentoxifylline 400 MG Details
NCT06651281 Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) PHASE3 RECRUITING Merck Sharp & Dohme LLC Crohn Disease|Colitis, Ulcerative DRUG: Tulisokibart|DRUG: Placebo to tulisokibart Details
NCT06681181 A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK4528287 in Healthy Participants PHASE1 RECRUITING GlaxoSmithKline Colitis, Ulcerative DRUG: GSK4528287|DRUG: Placebo Details
NCT04478825 Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis PHASE1 TERMINATED Bridge Biotherapeutics, Inc. Ulcerative Colitis DRUG: BBT-401-1S Details
NCT06321887 EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD PHASE3 RECRUITING Liverpool University Hospitals NHS Foundation Trust Inflammatory Bowel Disease|Iron Deficiency Anemia DRUG: Ferrous fumarate syrup 2.5ml/70mg (22.5mg e… Details
NCT02447302 Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis PHASE2 COMPLETED Arena Pharmaceuticals Ulcerative Colitis DRUG: Etrasimod|DRUG: Placebo Details
NCT05507203 ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 PHASE3 RECRUITING Abivax S.A. Ulcerative Colitis DRUG: ABX464|DRUG: Placebo Details
NCT04677179 A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) PHASE2 TERMINATED Nektar Therapeutics Colitis, Ulcerative DRUG: LY3471851|DRUG: Placebo Details
NCT05177835 Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis PHASE2 ACTIVE_NOT_RECRUITING Abivax S.A. Ulcerative Colitis DRUG: ABX464 Details
NCT04348890 Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis PHASE1|PHASE2 WITHDRAWN ReveraGen BioPharma, Inc. Pediatric Ulcerative Colitis DRUG: Vamorolone 4% suspension for oral dosing Details
NCT02958865 Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis PHASE2 COMPLETED Pfizer Ulcerative Colitis DRUG: PF-06651600 or Placebo|DRUG: PF-06700841 or… Details
NCT03943550 Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC) PHASE1 TERMINATED Hoffmann-La Roche Ulcerative Colitis DRUG: RO7049665|DRUG: Placebo Details
NCT02840721 Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis. PHASE2 COMPLETED Telavant, Inc. Colitis, Ulcerative DRUG: PF-06480605 Details
NCT05907330 Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis PHASE2 NOT_YET_RECRUITING Curacle Co., Ltd. Ulcerative Colitis DRUG: CU104|DRUG: Placebo Details
NCT04706793 Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN) PHASE3 COMPLETED Pfizer Ulcerative Colitis DRUG: Etrasimod|DRUG: Placebo Details
NCT04996797 A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005) PHASE2 ACTIVE_NOT_RECRUITING Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Ulcerative Colitis DRUG: Tulisokibart|DEVICE: Companion Diagnostic (… Details
NCT05507216 ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 PHASE3 RECRUITING Abivax S.A. Ulcerative Colitis DRUG: ABX464|DRUG: Placebo Details
NCT03093259 ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis PHASE2 COMPLETED Abivax S.A. Ulcerative Colitis DRUG: ABX464|DRUG: Placebo oral capsule Details
NCT01959282 A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis PHASE2 COMPLETED Janssen Research & Development, LLC Colitis, Ulcerative DRUG: Placebo|DRUG: JNJ-54781532 25 mg once daily… Details
NCT00659802 Phase II Study of HMPL-004 in Patients With Ulcerative Colitis PHASE2 COMPLETED Hutchison Medipharma Limited Ulcerative Colitis DRUG: HMPL-004 low dose|DRUG: Placebo|DRUG: HMPL-… Details

Disease IDDisease NameDefinitionCategoryRelated DrugsMechanism
No data available

Strategy IDTherapeutic StrategySynonymsRelated DrugsMechanism
S01 Anti-inflammatory inflammatory 5-Aminosalicylates (5-ASAs); corticosteroids Crohn's disease and ulcerative colitis are the two main com… Details
S06 Anti-fibrosis fibrosis; tissue remodelling GS-5745; STNM01 Tissue remodelling and destruction in patients with IBD is … Details
S07 Blockade of cytokine Cytokine signalling apremilast; roflumilast; filgotinib; tofacitinib; ABT494; ABT-874; ustekinumab; isankizumab; LY-2525623; AMG139; MEDI2079; guselkumab Various T-cell subsets, their differentiation pathways and … Details

The case of a bloody mess - Bictegravir/emtricitabine/tenofovir alafenamide ind…

PMID: 40089176
Year: 2025
Relationship Type: Association Score: 6.5

BACKGROUND: Fecal calprotectin is a marker used to differentiate inflammatory bowel disease versus irritable bowel syndrome and is relevant in the di…

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