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Daxas
Daxas is a Small molecule drug developed by AstraZeneca. It is currently in Phase 2 development for COPD Associated with Chronic Bronchitis, Plaque psoriasis, Severe chronic obstructive pulmonary disease.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Daxas |
|---|---|
| Sponsor | AstraZeneca |
| Target | cAMP-specific 3',5'-cyclic phosphodiesterase 4A, cAMP-specific 3',5'-cyclic phosphodiesterase 4B, cAMP-specific 3',5'-cyclic phosphodiesterase 4D |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Approved indications
- COPD Associated with Chronic Bronchitis
- Plaque psoriasis
- Severe chronic obstructive pulmonary disease
Common side effects
Key clinical trials
- The Role of Phosphodiesterase Inhibitors in Incretin Secretion (PHASE1)
- Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
- Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) (PHASE4)
- Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07) (PHASE3)
- Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05) (PHASE2, PHASE3)
- The Safety and Efficacy of Roflumilast Foam in HS (PHASE2)
- A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR) (PHASE3)
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
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:
- Daxas CI brief — competitive landscape report
- Daxas updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Daxas
What is Daxas?
What is Daxas used for?
Who makes Daxas?
What development phase is Daxas in?
What does Daxas target?
Related
- Target: All drugs targeting cAMP-specific 3',5'-cyclic phosphodiesterase 4A, cAMP-specific 3',5'-cyclic phosphodiesterase 4B, cAMP-specific 3',5'-cyclic phosphodiesterase 4D
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for COPD Associated with Chronic Bronchitis
- Indication: Drugs for Plaque psoriasis
- Indication: Drugs for Severe chronic obstructive pulmonary disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing