Fidanacogene Elaparvovec

Summary

Fidanacogene Elaparvovec (CHEMBL3990034) is an approved gene (ATC B02BD17); indicated across 3 conditions including hemophilia b.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Gene
• ATC class: B02BD17
• Indications: 3 conditions
• Clinical trials: 2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3990034
Name	Fidanacogene Elaparvovec
Type	Gene
Max phase	4
ATC	B02BD17

Also known as: Aav8 hfix19, Beqvez, Durveqtix, Fidanacogen elaparvovec, Fidanacogene elaparvovec, PF-06838435, SPK 101, SPK-1001, SPK-9001, SPK-FIX Padua, Spark 101, FIDANACOGENE ELAPARVOVEC

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

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

Indication	Phase	MONDO	EFO
hemophilia B	4	MONDO:0010604	MONDO:0010604

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

Clinical trials

Total trials: 2.

Phase distribution

Phase	Trials
PHASE3	1
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03861273	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
NCT02484092	PHASE2	COMPLETED	A Gene Therapy Study for Hemophilia B

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).