Drugs / SEL-212
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | gout | 2025-09-10 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA)” sobi.com ↗ |
| Filed | US (FDA) | — | gout | 2024-07-02 | “Sobi ® today announced the initiation of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SEL-212.” sobi.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02648269 | Dec 2015 → Dec 2016 | gout | Selecta Biosciences, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-09-10 | Sobi, Inc. | Regulatory FDA Accepts Biologics License Application for Sobi's NASP for Patients with Uncontrolled Gout sobi.com ↗
Sobi® (STO: SOBI), a global biopharmaceutical company dedicated to delivering innovative treatments for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) seeking approval for Nanoecapsulated Sirolimus plus Pegadricase (NASP), formerly SEL-212, for the treatment of uncontrolled gout. |
| 2024-07-02 | Sobi, Inc. | Regulatory Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout sobi.com ↗
Sobi ® today announced the initiation of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SEL-212. |
| 2023-03-21 | Sobi, Inc. | Results Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint sobi.com ↗
The DISSOLVE II (the “Global Study”) also met its primary endpoint, with 47% receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response. |
| 2020-09-30 | Sobi, Inc. | Results Sobi and Selecta Biosciences announce topline data of SEL-212 from the phase 2 COMPARE study supporting the potential for important clinical improvement in patients with Chronic Refractory Gout sobi.com ↗
Numerically higher response rate for SEL-212 versus pegloticase during primary endpoint of months 3 and 6 combined; statistically significant higher response rate for SEL-212 versus pegloticase during month 3 |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SEL-212 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02648269 ↗ |
| Route | Intravenous | “a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110” NCT02648269 ↗ |