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ADX-038 Dose Level 1
ADX-038 Dose Level 1 is a PI3K delta and gamma inhibitor Small molecule drug developed by ADARx Pharmaceuticals, Inc.. It is currently in Phase 2 development for Relapsed or refractory chronic lymphocytic leukemia (CLL).
ADX-038 is a small molecule inhibitor of the PI3K delta and PI3K gamma enzymes.
ADX-038 is a small molecule inhibitor of the PI3K delta and PI3K gamma enzymes. Used for Relapsed or refractory chronic lymphocytic leukemia (CLL).
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | ADX-038 Dose Level 1 |
|---|---|
| Sponsor | ADARx Pharmaceuticals, Inc. |
| Drug class | PI3K delta and gamma inhibitor |
| Target | PI3K delta and gamma |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
By inhibiting these enzymes, ADX-038 disrupts the PI3K/AKT signaling pathway, which is involved in cell proliferation and survival. This mechanism is thought to contribute to its anti-tumor effects.
Approved indications
- Relapsed or refractory chronic lymphocytic leukemia (CLL)
Common side effects
- Diarrhea
Key clinical trials
- Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease (PHASE2)
- Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients (PHASE1, 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:
- ADX-038 Dose Level 1 CI brief — competitive landscape report
- ADX-038 Dose Level 1 updates RSS · CI watch RSS
- ADARx Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about ADX-038 Dose Level 1
What is ADX-038 Dose Level 1?
How does ADX-038 Dose Level 1 work?
What is ADX-038 Dose Level 1 used for?
Who makes ADX-038 Dose Level 1?
What drug class is ADX-038 Dose Level 1 in?
What development phase is ADX-038 Dose Level 1 in?
What are the side effects of ADX-038 Dose Level 1?
What does ADX-038 Dose Level 1 target?
Related
- Drug class: All PI3K delta and gamma inhibitor drugs
- Target: All drugs targeting PI3K delta and gamma
- Manufacturer: ADARx Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory chronic lymphocytic leukemia (CLL)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing