Drugs / SAR447537
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05897424 | Jun 2024 → Jun 2028 expected | alpha 1-antitrypsin deficiency, pulmonary emphysema | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05856331 | Oct 2023 → Aug 2025 | alpha 1-antitrypsin deficiency, pulmonary emphysema | Sanofi | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-12-17 | Sanofi | Regulatory Press Release: Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema sanofi.com ↗
Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema |
| 2025-10-22 | Sanofi | Results Press Release: Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study sanofi.com ↗
It demonstrated a statistically significant greater mean increase in functional AAT levels within normal range as measured by trough concentrations at steady state compared to those receiving weekly plasma-derived augmentation therapy at week 32 [p<0.0001]. |
All press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAR447537 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05856331 ↗ |
| Known as | INBRX-101 | “Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema” NCT05897424 ↗1“Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema” NCT05856331 ↗ |
| Modality | Protein / enzyme biologic | “A1PI, Recombinant, Bivalent Fc Fusion Protein” NCT05856331 ↗ |
| Route | Intravenous | “IV every 3-weeks (Q3W) and placebo (normal saline)” NCT05856331 ↗ |