Drugs / SONALA-001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04559685 | Mar 2021 → Aug 2023 | high grade astrocytic tumor | Nader Sanai | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05123534 | Aug 2022 → Jul 2024 | diffuse intrinsic pontine glioma | SonALAsense, Inc. | Suspended | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-12-13 | SonALAsense, Inc. | Results SonALAsense presents preliminary data from clinical study in patients with deadly pediatric brain tumor sonalasense.com ↗
The preliminary data from Study SDT-201 shows signals of clinical activity and no safety concerns. |
| 2023-11-14 | SonALAsense, Inc. | Regulatory FDA Grants Fast Track Designation to SonALAsense’s SONALA-001 in Combination with the INSIGHTEC Transcranial Ultrasound Device for Sonodynamic Therapy of DIPG, a Rare Pediatric Brain Cancer sonalasense.com ↗
SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device for the treatment of patients with diffuse intrinsic pontine glioma (DIPG). |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SONALA-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04559685 ↗ |
| Known as | ALA | “SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)” NCT05123534 ↗ |
| Route | Intravenous | “5 mg/kg IV SONALA-001 (ALA)” NCT05123534 ↗ |