SAPHNELO
PeakmAbBLAINJECTIONINJECTABLE
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SAPHNELO (anifrolumab-fnia) is a monoclonal antibody that antagonizes the Type I Interferon receptor, blocking interferon-driven inflammation in systemic lupus erythematosus (SLE). It is administered via subcutaneous injection and represents a novel mechanism targeting the interferon pathway in autoimmune disease.
$9MPart D
PeakProduct is in peak revenue phase with modest Medicare utilization, indicating an established commercial infrastructure and mid-sized team managing a niche autoimmune franchise.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Saphnelo Use in Females of Child-bearing Potential
Started Oct 2026
26,000,000 enrolled
Systemic Lupus Erythematosus
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus
Started Aug 2026
417 enrolled
Lupus Erythematosus, Systemic
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Started Aug 2026
1,072 enrolled
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Anifrolumab Pregnancy Study
Started Jun 2026
500 enrolled
Systemic Lupus Erythematosus
Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)
Started Apr 2026
20 enrolled
Antiphospholipid Syndrome (APS)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.