Aqneursa (levacetylleucine)

Ataxia-telangiectasia

Also known as IB1001

Manufacturer: IntraBio
Regulatory submission: sNDA submitted March 2026 and approved September 2026
Launch: Commercially available at approval in September 2026
Last updated: October 2, 2026

Section

Product information and disease description Place of product in therapy

Approaches to treatment

106 evidence topics · 46 sources

Current treatment options and standard of care52 evidence topics · 29 sources
Place in treatment, anticipated use, and care setting7 evidence topics · 6 sources
Heterogeneity of treatment effect7 evidence topics · 4 sources
Care management intervention strategies12 evidence topics · 7 sources
Other product development or post-marketing obligations required by the FDA10 evidence topics · 5 sources
Ongoing post-approval monitoring6 evidence topics · 6 sources
Expected outcomes of therapy12 evidence topics · 9 sources