SAPHNELO (anifrolumab-fnia)
SAPHNELO is indicated for the treatment of Systemic Lupus Erythematosus.
How SAPHNELO Works
Anifrolumab-fnia is a monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR), blocking the signaling and biological activity of type I interferons. This inhibition suppresses the expression of interferon-responsive genes and reduces downstream inflammatory and immunological processes, such as plasma cell differentiation. The drug also induces the internalization of the receptor, which decreases the amount of IFNAR1 available on the cell surface. These combined actions help normalize peripheral T-cell subsets and address the biological pathways involved in the pathogenesis of SLE.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-07-30
- Routes
- INJECTION, SINGLE-USE
- Dosage Forms
- INJECTABLE, INJECTION, VIAL
SAPHNELO Approval History
What SAPHNELO Treats
1 indicationsSAPHNELO is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Systemic Lupus Erythematosus
SAPHNELO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SAPHNELO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SAPHNELO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SAPHNELO
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07584083 AnifAPS | ESR-23-22244 2025-520918-64-00 | Ph 2 | not yet recruiting | Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial) |
| NCT06594068 PRIMULA Lac | D3461R00052 | Ph 4 | recruiting | Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users |
| NCT05835310 BLOSSOM | D3461C00030 2022-502289-25-00 | Ph 3 | recruiting | An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants |
| NCT07430306 SUNFLOWER | D3461C00040 | Ph 3 | recruiting | A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus |
| NCT05440422 | 10000682 000682-AR | Ph 2 | recruiting | The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD |
| NCT05138133 IRIS | D3466C00001 2021-002862-42 | Ph 3 | active not recruiting | Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis |
| NCT06374212 | 24-0191 | Ph 2 | active not recruiting | Anifrolumab for Hidradenitis Suppurativa |
| NCT04931563 results posted | D3468C00003 | Ph 3 | completed | Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) |
| NCT06662123 | D3465C00004 | Ph 1 | completed | Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants |
| NCT05339100 | D3465C00002 2021-004896-14 | Ph 1 | completed | Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab |
| NCT02794285 TULIP SLE LTE results posted | D3461C00009 | Ph 3 | completed | Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus |
| NCT02962960 results posted | D3461C00008 | Ph 2 | completed | A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations |
| NCT02446912 results posted | D3461C00005 | Ph 3 | completed | Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus |
| NCT02446899 results posted | D3461C00004 | Ph 3 | completed | Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus |
| NCT05001698 | D3468C00002 | Ph 1 | completed | Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE) |
| NCT02547922 TULIP-LN1 results posted | D3461C00007 | Ph 2 | completed | Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis |
| NCT01753193 results posted | CD-IA-MEDI-546-1145 2012-004619-30 | Ph 2 | completed | An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SAPHNELO FDA Label Details
Indications & Usage
FDA Label (PDF)SAPHNELO is indicated for the treatment of Systemic Lupus Erythematosus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment