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TCH346 · 3 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| TCH346 | DRUG | - |
Inclusion Criteria: * Completed original protocol, Study No. CTCH346A2211 * Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained Exclusion Criteria: * Exclusion criteria as described ...
TCH346 is an investigational small molecule being developed for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It has been studied in Phase 2 clinical trials, but it is not approved and remains in clinical development.
TCH346 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company has sponsored multiple clinical trials evaluating the drug in patients with ALS.
TCH346 is in Phase 2 clinical development. Three Phase 2 trials have been completed, including a dose-ranging study, a placebo-controlled efficacy study, and a long-term extension study. The drug is investigational and has not received FDA approval.
TCH346 has been studied in three completed Phase 2 trials. NCT00036413 was a 12-week dose-ranging study in 44 patients. NCT00072709 was a placebo-controlled study in 551 patients across multiple countries. NCT00230074 was a long-term extension study in 350 patients.
TCH346 is the sole name used for this investigational compound in the clinical trial records. No alternative names have been associated with the drug in the available data, and it is distinct from other ALS therapies.