DrugBiological

IB1001 clinical trials

Also written IB1001.

studies test it: 7
open now: 0
in phase 3: 4
first study started: 2009

How each study uses IB1001 is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Approvals

The first approval found in each region, with its record

United States: Not in FDA's approval records
European Union: Not in EMA's list of EU-wide authorisations

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

IXINITY: 3
N-Acetyl-L-Leucine: 3
Recombinant factor IX: 2

Development codes

IB1001: 7
APVO101: 1

Studies by the year they started

7 studies that test it; most in 2019 (2)

Studies that test IB1001, by start year
Year	Studies
2009	1
2010	1
2014	1
2019	2
2020	2

By phase

A phase 1/2 study counts in both.

Phase 2: 4
Phase 3: 4

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Hemophilia B: 4
Gangliosidoses, GM2: 1
Niemann-Pick Disease, Type C: 1
Ataxia Telangiectasia: 1

Who runs them

Industry 7 · Other 0

Medexus Pharma, Inc. (3) · IntraBio Inc (3) · Cangene Corporation (1)

Studies

Open first, then newest update. How each study uses IB1001 is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.