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Adezunap (AP707)
Adezunap (AP707) is a Adenosine deaminase inhibitor Small molecule drug developed by Apurano Pharmaceuticals GmbH. It is currently in Phase 3 development for Autoimmune hepatitis, Primary biliary cholangitis.
Adezunap is a small-molecule inhibitor of adenosine deaminase that increases intracellular adenosine and deoxyadenosine levels to promote immune cell apoptosis and reduce inflammation.
Adezunap (AP707) is being studied for its efficacy and tolerability in patients with chronic pain due to diabetic polyneuropathy. Clinical trials are investigating Adezunap for conditions including pain, chronic pain, and chronic pain syndrome.
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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 | Adezunap (AP707) |
|---|---|
| Sponsor | Apurano Pharmaceuticals GmbH |
| Drug class | Adenosine deaminase inhibitor |
| Target | Adenosine deaminase (ADA) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting adenosine deaminase (ADA), adezunap causes accumulation of adenosine and deoxyadenosine, which are toxic to lymphocytes and promote their selective elimination. This mechanism is intended to reduce pathogenic immune responses in autoimmune and inflammatory conditions. The drug targets the purine metabolism pathway to achieve immunosuppressive effects.
Approved indications
- Autoimmune hepatitis
- Primary biliary cholangitis
Common side effects
- Lymphopenia
- Nausea
- Diarrhea
- Elevated liver enzymes
Key clinical trials
- Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy (PHASE3)
- Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain (PHASE3)
- Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis (PHASE3)
- Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis (PHASE3)
- Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy (PHASE3)
- Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy (PHASE3)
- Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain (PHASE3)
- Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy (PHASE3)
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:
- Adezunap (AP707) CI brief — competitive landscape report
- Adezunap (AP707) updates RSS · CI watch RSS
- Apurano Pharmaceuticals GmbH portfolio CI
Frequently asked questions about Adezunap (AP707)
What is Adezunap (AP707)?
How does Adezunap (AP707) work?
What is Adezunap (AP707) used for?
Who makes Adezunap (AP707)?
What drug class is Adezunap (AP707) in?
What development phase is Adezunap (AP707) in?
What are the side effects of Adezunap (AP707)?
What does Adezunap (AP707) target?
Related
- Drug class: All Adenosine deaminase inhibitor drugs
- Target: All drugs targeting Adenosine deaminase (ADA)
- Manufacturer: Apurano Pharmaceuticals GmbH — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Autoimmune hepatitis
- Indication: Drugs for Primary biliary cholangitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing