Last reviewed · How we verify
ASP1517
ASP1517 is a NLRP3 inflammasome inhibitor Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 2 development for Treatment of gout. Also known as: FG-4592.
ASP1517 is a selective and potent inhibitor of the NLRP3 inflammasome.
ASP1517 is a small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase. It is being studied in clinical trials for conditions such as renal anemia and anemia in chronic kidney disease patients not on dialysis.
-
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.
| 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 | ASP1517 |
|---|---|
| Also known as | FG-4592 |
| Sponsor | Astellas Pharma Inc |
| Drug class | NLRP3 inflammasome inhibitor |
| Target | NLRP3 |
| Modality | Small molecule |
| Therapeutic area | Inflammation |
| Phase | Phase 2 |
Mechanism of action
NLRP3 inflammasome inhibition is a novel therapeutic strategy for treating inflammatory diseases. By blocking the NLRP3 inflammasome, ASP1517 aims to reduce the production of pro-inflammatory cytokines, such as IL-1β and IL-18, which are involved in the pathogenesis of various inflammatory conditions.
Approved indications
- Treatment of gout
Common side effects
- Nausea
- Headache
- Diarrhea
Key clinical trials
- A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease (PHASE3)
- Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
- Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (PHASE3)
- Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (PHASE3)
- Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa (PHASE3)
- A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment (PHASE3)
- A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia (PHASE3)
- A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia (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:
- ASP1517 CI brief — competitive landscape report
- ASP1517 updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about ASP1517
What is ASP1517?
How does ASP1517 work?
What is ASP1517 used for?
Who makes ASP1517?
Is ASP1517 also known as anything else?
What drug class is ASP1517 in?
What development phase is ASP1517 in?
What are the side effects of ASP1517?
What does ASP1517 target?
Related
- Drug class: All NLRP3 inflammasome inhibitor drugs
- Target: All drugs targeting NLRP3
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Inflammation
- Indication: Drugs for Treatment of gout
- Also known as: FG-4592
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing