Azafaros B.V.

Azafaros B.V. works on 4 rare diseases tracked on Trial Friend, including Gaucher Disease, Niemann-Pick Disease, Niemann-Pick Disease Type C and 1 more, with 4 recruiting clinical trials.

Azafaros is a clinical-stage biotechnology company developing brain-penetrant, oral small-molecule therapies for rare lysosomal storage disorders. The company was spun out from research at Leiden University and Amsterdam UMC. Lead program nizubaglustat targets both Niemann-Pick disease type C and GM1/GM2 gangliosidoses, with positive Phase 2 topline data reported.

Type
Rare Disease Specialist
Headquarters
Leiden, Netherlands
Founded
2018
4
Active Rare Disease Trials
4
Rare Diseases in Portfolio
8
Years Active

Focus areas at Azafaros B.V.

As a rare disease specialist, Azafaros B.V. has active clinical trial programs and drug development efforts across 4 rare diseases, including Gaucher Disease, Niemann-Pick Disease, Niemann-Pick Disease Type C, Tay-Sachs Disease. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Azafaros B.V., sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Azafaros B.V. is headquartered in Leiden, Netherlands, founded in 2018. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Azafaros B.V. Drug Pipeline

Azafaros B.V. has 4 active clinical trials across 2 development stages, with 4 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Azafaros B.V.'s active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Azafaros B.V.'s pipeline
Type your own question with a little about your situation, and get an answer with sources.
Tap to start:
Or start with one of these
1
Phase 21 trial
Recruiting
3
Phase 33 trials
Gangliosidoses, GM2+1 more
Recruiting

Azafaros B.V. Clinical Trials (4)

Active and recruiting clinical trials sponsored by Azafaros B.V., sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Azafaros B.V.'s trials
Type your own question with a little about your situation, and get an answer with sources.
Tap to start:
Or start with one of these
RECRUITINGPHASE3Recently updatedNCT07082725

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease (NPC)

Intervention: Nizubaglustat, Placebo

An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease

Ages 4 Years+34 locations
View full study
RECRUITINGPHASE3Recently updatedNCT07054515

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease, GM1 Gangliosidosis or GM2 Gangliosidosis

Intervention: AZ-3102, Placebo

An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease and in late-infantile and juvenile-onset forms of GM1 gangliosidosis or GM2 gangliosidosis

Ages 4 Years+39 locations
View full study
ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT07082543

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis

Intervention: AZ-3102, Placebo

Gangliosidoses, GM2Gangliosidosis, GM1

An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of GM1 gangliosidosis or GM2 gangliosidosis

Ages 4 Years+27 locations
View full study
RECRUITINGPHASE2Updated a few months agoNCT07399704

A Study to Evaluate the Safety and Efficacy of Nizubaglustat (AZ-3102) in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease

Intervention: AZ-3102

This open-label study aims to gather long-term safety, tolerability, PK, biomarker, and clinical efficacy data relating to daily administration of Nizubaglustat in participants previously enrolled in the Phase 2 RAINBOW study (Cohort 1). In addition, the study aims to assess safety, clinical, and biochemical impact of transitioning NPC disease patients to Nizubaglustat after prior treatment with stable, full-dose Miglustat (Cohort 2).

Ages 12 Years+3 locations
View full study

FDA-Approved Drugs

No FDA-approved drugs found for this company at this time.

Azafaros B.V. Trial Locations

Azafaros B.V. clinical trials are running at 103 sites in 17 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
15▼
Brazil
11▼
India
11▼
Turkey (Türkiye)
9▼
Australia
7▼
Canada
7▼
Spain
6▼
United Kingdom
6▼
Argentina
5▼
Portugal
5▼
Mexico
4▼
France
4▼

Rare Disease Focus Areas (4)

Diseases targeted by Azafaros B.V.'s clinical trial and drug development programs

Patient Resources

Organizations and resources related to Azafaros B.V.'s rare disease focus areas

Frequently Asked Questions About Azafaros B.V.

Common questions about Azafaros B.V.'s rare disease programs, clinical trials, and treatments.