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AZA capsules
AZA capsules is a Immunosuppressant Small molecule drug developed by Centre Hospitalier Universitaire, Amiens. It is currently in Phase 3 development for Moderate to severe ulcerative colitis, Moderate to severe Crohn's disease.
AZA capsules work by inhibiting the enzyme myeloperoxidase, which is involved in the production of reactive oxygen species.
AZA capsules are used in clinical trials for the treatment of Non-Small-Cell Lung Cancer and Chronic Obstructive Pulmonary Disease. AZA capsules are also used in combination with other treatments, such as erlotinib, for the treatment of Advanced Non-Small Cell Lung Cancer.
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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.
| 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 | AZA capsules |
|---|---|
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Drug class | Immunosuppressant |
| Target | Myeloperoxidase |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting myeloperoxidase, AZA capsules reduce the production of reactive oxygen species, which can damage tissues and contribute to various inflammatory and autoimmune diseases. This mechanism is thought to be beneficial in conditions such as ulcerative colitis and Crohn's disease.
Approved indications
- Moderate to severe ulcerative colitis
- Moderate to severe Crohn's disease
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
Key clinical trials
- Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia (EARLY_PHASE1)
- A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) (PHASE2, PHASE3)
- Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia (PHASE1)
- FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia (PHASE1)
- Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia (PHASE1)
- Modulation of Stem Cell Differentiation in Individuals With High Risk Clonal Haematopoiesis (PHASE2)
- Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy (PHASE2)
- A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures (NA)
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:
- AZA capsules CI brief — competitive landscape report
- AZA capsules updates RSS · CI watch RSS
- Centre Hospitalier Universitaire, Amiens portfolio CI
Frequently asked questions about AZA capsules
What is AZA capsules?
How does AZA capsules work?
What is AZA capsules used for?
Who makes AZA capsules?
What drug class is AZA capsules in?
What development phase is AZA capsules in?
What are the side effects of AZA capsules?
What does AZA capsules target?
Related
- Drug class: All Immunosuppressant drugs
- Target: All drugs targeting Myeloperoxidase
- Manufacturer: Centre Hospitalier Universitaire, Amiens — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Moderate to severe ulcerative colitis
- Indication: Drugs for Moderate to severe Crohn's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing