The FDA approved AstraZeneca’s Saphnelo Pen for once-weekly self-administration in adults with systemic lupus erythematosus. Approval was based on Phase III TULIP-SC results showing reduced disease activity versus placebo.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
New research demonstrates machine learning can optimize drug dosing, identifies biomarkers of treatment response, and validates prognostic criteria for long-term kidney survival in pediatric lupus nephritis patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07751848 |
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | PHASE3 |
| NCT07691970 |
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment |
NOT_YET_RECRUITING | PHASE3 |
| NCT07584083 |
Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial) |
RECRUITING | PHASE2 |
| NCT07430306 |
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus |
RECRUITING | PHASE3 |
| NCT07330245 |
Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. |
RECRUITING | |
| NCT07000110 |
Anifrolumab Malignancy and Serious Infections Study |
RECRUITING | |
| NCT06795893 |
The Anifrolumab PRIM Program |
RECRUITING | |
| NCT06673043 |
Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus |
ACTIVE_NOT_RECRUITING | |
| NCT06659029 |
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users |
RECRUITING | |
| NCT06594068 |
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users |
RECRUITING | PHASE4 |
