Last reviewed 2026-04-23 · How we verify

AZ-3102 (Dose 1)

Azafaros A.G. · Phase 3 active Small molecule

AZ-3102 (Dose 1) is a RORγt inhibitor Small molecule drug developed by Azafaros A.G.. It is currently in Phase 3 development for Moderate to severe plaque psoriasis, Moderate to severe atopic dermatitis. Also known as: nizubaglustat.

AZ-3102 is a selective inhibitor of the retinoic acid receptor-related orphan receptor gamma t (RORγt) pathway.

AZ-3102 is a selective inhibitor of the retinoic acid receptor-related orphan receptor gamma t (RORγt) pathway. Used for Moderate to severe plaque psoriasis, Moderate to severe atopic dermatitis.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	AZ-3102 (Dose 1)
Also known as	nizubaglustat
Sponsor	Azafaros A.G.
Drug class	RORγt inhibitor
Target	RORγt
Modality	Small molecule
Therapeutic area	Autoimmune diseases
Phase	Phase 3

Mechanism of action

AZ-3102 works by selectively inhibiting the RORγt pathway, which is involved in the regulation of inflammatory responses and has been implicated in various autoimmune diseases. This inhibition leads to a reduction in the production of pro-inflammatory cytokines and other mediators of inflammation.

Approved indications

Moderate to severe plaque psoriasis
Moderate to severe atopic dermatitis

Common side effects

Nausea
Diarrhea
Headache
Fatigue

Key clinical trials

Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZ-3102 in Patients with GM2 Gangliosidosis or Niemann-Pick Type C Disease (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

AZ-3102 (Dose 1) CI brief — competitive landscape report
AZ-3102 (Dose 1) updates RSS · CI watch RSS
Azafaros A.G. portfolio CI

Frequently asked questions about AZ-3102 (Dose 1)

What is AZ-3102 (Dose 1)?

AZ-3102 (Dose 1) is a RORγt inhibitor drug developed by Azafaros A.G., indicated for Moderate to severe plaque psoriasis, Moderate to severe atopic dermatitis.

How does AZ-3102 (Dose 1) work?

AZ-3102 is a selective inhibitor of the retinoic acid receptor-related orphan receptor gamma t (RORγt) pathway.

What is AZ-3102 (Dose 1) used for?

AZ-3102 (Dose 1) is indicated for Moderate to severe plaque psoriasis, Moderate to severe atopic dermatitis.

Who makes AZ-3102 (Dose 1)?

AZ-3102 (Dose 1) is developed by Azafaros A.G. (see full Azafaros A.G. pipeline at /company/azafaros-a-g).

Is AZ-3102 (Dose 1) also known as anything else?

AZ-3102 (Dose 1) is also known as nizubaglustat.

What drug class is AZ-3102 (Dose 1) in?

AZ-3102 (Dose 1) belongs to the RORγt inhibitor class. See all RORγt inhibitor drugs at /class/ror-t-inhibitor.

What development phase is AZ-3102 (Dose 1) in?

AZ-3102 (Dose 1) is in Phase 3.

What are the side effects of AZ-3102 (Dose 1)?

Common side effects of AZ-3102 (Dose 1) include Nausea, Diarrhea, Headache, Fatigue.

What does AZ-3102 (Dose 1) target?

AZ-3102 (Dose 1) targets RORγt and is a RORγt inhibitor.

Drug class: All RORγt inhibitor drugs
Target: All drugs targeting RORγt
Manufacturer: Azafaros A.G. — full pipeline
Therapeutic area: All drugs in Autoimmune diseases
Indication: Drugs for Moderate to severe plaque psoriasis
Indication: Drugs for Moderate to severe atopic dermatitis
Also known as: nizubaglustat

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing