Baloxavir Marboxil

Summary

Baloxavir Marboxil (CHEMBL4297503) is an approved small molecule (ATC J05AX25); indicated across 5 conditions including viral infectious disease and influenza.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AX25
• Indications: 5 conditions
• Clinical trials: 19
• Chemistry: 571.6 Da · C27H23F2N3O7S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297503
Name	Baloxavir Marboxil
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	124081896
ATC	J05AX25
Molecular formula	C27H23F2N3O7S
Molecular weight	571.6
InChIKey	RZVPBGBYGMDSBG-GGAORHGYSA-N

SMILES: COC(=O)OCOC1=C2C(=O)N3CCOC[C@H]3N(N2C=CC1=O)[C@H]4C5=C(CSC6=CC=CC=C46)C(=C(C=C5)F)F

IUPAC name: [(3R)-2-[(11S)-7,8-difluoro-6,11-dihydrobenzo[c][1]benzothiepin-11-yl]-9,12-dioxo-5-oxa-1,2,8-triazatricyclo[8.4.0.03,8]tetradeca-10,13-dien-11-yl]oxymethyl methyl carbonate

Also known as: Baloxavir marboxil, S-033188, Xofluza, BALOXAVIR MARBOXIL, Baloxavir marboxil; XOFLUZA, baloxavir marboxil, Baloxavir Marboxil

Patent coverage: 611 distinct patent families (1,309 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 1,255 (96%) 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

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Polymerase acidic protein.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 1 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
P03433	6.28	IC50	530	nM	CHEMBL_ACT_25050396

Target pathways

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

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
viral infectious disease	4	MONDO:0005108	EFO:0000763
influenza	4	MONDO:0005812	EFO:0007328

2 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
pneumonia	3	MONDO:0005249	EFO:0003106
severe acute respiratory syndrome	3	MONDO:0005091	MONDO:0100096

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

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE3	12
Not specified	3
PHASE4	2
PHASE2/PHASE3	1
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04141930	PHASE4	COMPLETED	Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
NCT06161454	PHASE4	COMPLETED	Xofluza-Wearables Feasibility-Study
NCT02735707	PHASE3	RECRUITING	Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT04381936	PHASE3	RECRUITING	Randomised Evaluation of COVID-19 Therapy
NCT06094010	PHASE3	RECRUITING	A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
NCT06653569	PHASE3	RECRUITING	Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)
NCT02949011	PHASE3	COMPLETED	Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
NCT02954354	PHASE3	COMPLETED	A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
NCT03629184	PHASE3	COMPLETED	Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
NCT03653364	PHASE3	COMPLETED	Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
NCT03684044	PHASE3	COMPLETED	Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
NCT03969212	PHASE3	COMPLETED	Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
NCT05170009	PHASE2/PHASE3	TERMINATED	Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza
NCT06507813	PHASE3	COMPLETED	Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
NCT06774859	PHASE3	COMPLETED	Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
NCT04712539	PHASE2	RECRUITING	Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
NCT06762587	Not specified	NOT_YET_RECRUITING	Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting
NCT03959332	Not specified	COMPLETED	Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
NCT06207058	Not specified	TERMINATED	Evaluation of a Screen and Treat Protocol for Influenza

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).