tividenofusp alfa

Phase 3Small molecule

DDenali Therapeutics Inc.

tividenofusp alfa is one of 10 small molecule programs targeting Mucopolysaccharidosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

MucopolysaccharidosisEnrolling by invitation

Hunter SyndromeActive, not recruiting

MucopolysaccharidosisPhase 3

Enrolling by invitation

Hunter SyndromePhase 2

Active, not recruiting

Competition

Competitive Landscape

9 competitors in Mucopolysaccharidosis

#DrugCompanyPhaseTrials

Rituxan

Roche

Approved

1 2

Trexall

Jazz Pharmaceuticals

Approved

1 3

Neoral

Novartis

Approved

—4

Imuran

LLegacy Health System

Approved

—5

JR-141

JJCR Pharmaceuticals Co., Ltd.

Phase 3

4 6

tividenofusp alfa

DDenali Therapeutics Inc.

Phase 3

1 7

GNR-055

AAO GENERIUM

Phase 3

1 8

JR-446

JJCR Pharmaceuticals Co., Ltd.

Phase 2

2 9

Enzyme Replacement Agent

FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Preclinical

1 10

Laronidase ERT

MMasonic Cancer Center, University of Minnesota

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

PreclinicalActive, not recruiting

Mucopolysaccharidosis II

NCT05371613

Q1 2031

Phase 1/2Active, not recruiting

Hunter Syndrome

NCT04251026

Clinical

Trials by Indication[1]

Mucopolysaccharidosis1 trial

An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

Enrolling by invitation·DDenali Therapeutics Inc.·Phase 2/3·NCT06075537·99 enrolled

Hunter Syndrome1 trial

A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

Active, not recruiting·DDenali Therapeutics Inc.·Phase 1/2·NCT04251026·47 enrolled

Mucopolysaccharidosis II1 trial

A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II

Active, not recruiting·DDenali Therapeutics Inc.·Preclinical·NCT05371613·65 enrolled

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for tividenofusp alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — tividenofusp alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for tividenofusp alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Denali Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDenali Therapeutics Inc.

tividenofusp alfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q1 2031

Trials by Indication[1]

Mucopolysaccharidosis1 trial

Hunter Syndrome1 trial

Mucopolysaccharidosis II1 trial

References

Drug Info

Quick Facts

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