Fostemsavir

Summary

Fostemsavir (CHEMBL3301594) is an approved small molecule (ATC J05AX29); indicated across 3 conditions including hiv infectious disease and viral infectious disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AX29
• Indications: 3 conditions
• Clinical trials: 23
• Chemistry: 583.5 Da · C25H26N7O8P

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3301594
Name	Fostemsavir
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	11319217
ATC	J05AX29
Molecular formula	C25H26N7O8P
Molecular weight	583.5
InChIKey	SWMDAPWAQQTBOG-UHFFFAOYSA-N

SMILES: CC1=NN(C=N1)C2=NC=C(C3=C2N(C=C3C(=O)C(=O)N4CCN(CC4)C(=O)C5=CC=CC=C5)COP(=O)(O)O)OC

IUPAC name: [3-[2-(4-benzoylpiperazin-1-yl)-2-oxoacetyl]-4-methoxy-7-(3-methyl-1,2,4-triazol-1-yl)pyrrolo[2,3-c]pyridin-1-yl]methyl dihydrogen phosphate

Also known as: BMS-663068, Bms-663068 free acid, Fostemsavir, FOSTEMSAVIR

Parent form; salt/anhydrous children: CHEMBL3301598

Patent coverage: 166 distinct patent families (459 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 458 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
HIV infectious disease	4	MONDO:0005109	EFO:0000764
viral infectious disease	4	MONDO:0005108	EFO:0000763

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 23.

Phase distribution

Phase	Trials
PHASE1	16
PHASE2	3
PHASE3	2
PHASE1/PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02362503	PHASE3	ACTIVE_NOT_RECRUITING	Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
NCT07393659	PHASE3	NOT_YET_RECRUITING	A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment
NCT04648280	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
NCT07030920	PHASE2	RECRUITING	Reducing Systemic Inflammation in People on Antiretroviral Therapy
NCT01009814	PHASE2	COMPLETED	Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1
NCT01384734	PHASE2	COMPLETED	HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
NCT07053384	PHASE1	ACTIVE_NOT_RECRUITING	A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
NCT02063360	PHASE1	COMPLETED	DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
NCT02138084	PHASE1	COMPLETED	Drug-drug Interaction (DDI) Rifabutin
NCT02164045	PHASE1	COMPLETED	Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529
NCT02234882	PHASE1	COMPLETED	Study on Pharmacokinetics
NCT02277600	PHASE1	COMPLETED	A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
NCT02467335	PHASE1	COMPLETED	Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
NCT02480881	PHASE1	COMPLETED	A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
NCT02480894	PHASE1	COMPLETED	A Open-label, Drug-Drug Interaction With Maraviroc (DDI)
NCT02508064	PHASE1	COMPLETED	Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet
NCT02666001	PHASE1	COMPLETED	A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
NCT02666053	PHASE1	COMPLETED	A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects
NCT02674581	PHASE1	COMPLETED	A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)
NCT02805556	PHASE1	COMPLETED	Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
NCT02859259	PHASE1	COMPLETED	A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects
NCT04757974	PHASE1	COMPLETED	Low-dose Fostemsavir Extended Release Relative Bioavailability Study
NCT04233047	Not specified	AVAILABLE	Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).