Approval Probability
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Adjusted LOA
ML Risk
ALTO-101 · 1 trial · 2 indications
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
| Arm | Type | Description |
|---|---|---|
| ALTO-101 | EXPERIMENTAL | 10 days administration of ALTO-101T transdermal delivery system |
| Placebo | PLACEBO_COMPARATOR | 10 days administration of placebo transdermal delivery system |
| Name | Type | Description |
|---|---|---|
| ALTO-101 | DRUG | ALTO-101 patches |
| ALTO-101 Transdermal Delivery System | DEVICE | ALTO-101 transdermal delivery system |
| Placebo | DRUG | Inactive placebo patches |
| Placebo Transdermal Delivery System | DEVICE | Placebo transdermal delivery system |
Inclusion Criteria: * Schizophrenia diagnosis for at least one year * Cognitive impairment * Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2 * Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening * Have a bod...
ALTO-101 is an investigational small molecule being developed for the treatment of cognitive impairment associated with schizophrenia. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in patients with schizophrenia to evaluate its effects on cognitive symptoms.
ALTO-101 is being developed by Alto Neuroscience, Inc., a biopharmaceutical company publicly traded under the ticker symbol ANRO. The company is conducting clinical trials to evaluate the safety and efficacy of ALTO-101 in patients with schizophrenia.
ALTO-101 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is recruiting patients with schizophrenia and cognitive impairment to assess the drug's efficacy and safety.
ALTO-101 is being studied in a Phase 2 clinical trial with the identifier NCT06502964, titled "Study of ALTO-101 in Patients With Schizophrenia." This randomized, double-blind, placebo-controlled trial is recruiting 82 participants in the United States and is currently in the recruiting stage.
No, ALTO-101 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials. The FDA has granted Fast Track designation for ALTO-101, which is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.