Drugs / ABBV-CLS-628
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06902558 | Jun 2025 → Aug 2029 expected | autosomal dominant polycystic kidney disease | Calico Life Sciences LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-11-05 | Calico Life Sciences LLC | Regulatory Calico Life Sciences Announces U.S. FDA Orphan Drug Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease calicolabs.com ↗
Calico Life Sciences LLC (Calico), a biotechnology organization focused on aging and age-related diseases and founded by Alphabet Inc. and Arthur D. Levinson, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). |
| 2025-10-02 | Calico Life Sciences LLC | Regulatory Calico Life Sciences Announces U.S. FDA Fast Track Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease calicolabs.com ↗
“We are pleased that ABBV-CLS-628 has been granted Fast Track Designation,” said Arthur D. Levinson, Ph.D., CEO of Calico. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-05 | Calico Life Sciences LLC | Calico Life Sciences Announces U.S. FDA Orphan Drug Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease calicolabs.com ↗ |
| 2025-10-02 | Calico Life Sciences LLC | Calico Life Sciences Announces U.S. FDA Fast Track Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease calicolabs.com ↗ |
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 | ABBV-CLS-628 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06902558 ↗ |
| Route | Intravenous | “IntraVenous Infusion” NCT06902558 ↗ |