Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPD544 · 1 trial · 1 indication
AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
| Arm | Type | Description |
|---|---|---|
| SPD544 (Equasym XL) | EXPERIMENTAL | - |
| Methylphenidate hydrochloride (Metadate CD ) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SPD544 | DRUG | two 30mg capsules, single oral dose |
| Methylphenidate hydrochloride | DRUG | one 60mg capsule, single oral dose |
Inclusion criteria: 1. Healthy subjects, aged 18-55 years inclusive at the time of consent. 2. Subject must be willing to comply with applicable contraceptive requirements of the protocol and be: * Male, or * Non-pregnant, non-lactating female who must be \>90 days post-partum or nulliparous...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
SPD544 is an investigational small molecule being developed for the treatment of attention deficit hyperactivity disorder (ADHD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
SPD544 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug for the treatment of ADHD.
SPD544 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
SPD544 has one completed clinical trial, NCT01183234, titled "SPD544 High Strength Bioequivalence Study." This Phase 1 study enrolled 28 participants in the United Kingdom and assessed the drug in healthy volunteers aged 18 years and older.
SPD544 is a distinct investigational compound developed by Takeda Pharmaceutical Company Limited. No alternative names for SPD544 have been disclosed in the available clinical trial information.