Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATI355 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ATI355 | DRUG | - |
Inclusion criteria * Acute spinal cord injury paraplegic and tetraplegic patients with confirmed classification of ASIA A (C5 ≤ lesion ≤ T12; 4-14 days post-injury (i.e. study drug treatment must begin 4-14 days post injury) for paraplegic patients and for those tetraplegic patients who do not requ...
ATI355 is an investigational small molecule being developed for acute spinal cord injury. It is administered intrathecally, meaning directly into the spinal fluid, and is intended for patients with this condition. The drug is currently in clinical development and is not approved for use.
ATI355 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and tolerability of ATI355 in patients with acute spinal cord injury.
ATI355 is in Phase 1 clinical development. A Phase 1 trial has been completed, which focused on assessing the safety, tolerability, feasibility, and pharmacokinetics of the drug. ATI355 remains investigational and has not received regulatory approval.
ATI355 has one completed clinical trial, registered as NCT00406016. This Phase 1 study evaluated the acute safety, tolerability, feasibility, and pharmacokinetics of intrathecally administered ATI355 in patients with acute spinal cord injury. The trial enrolled 52 participants across Canada, Germany, and Switzerland.
ATI355 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety and tolerability, and further studies would be needed to establish efficacy and seek regulatory approval.