Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HLD100 · 1 trial · 1 indication
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
| Arm | Type | Description |
|---|---|---|
| HLD100 10mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) |
| HLD100 20mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) |
| HLD100 30mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) |
| HLD100 40mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) |
| Name | Type | Description |
|---|---|---|
| HLD100 | DRUG | Treatment |
Inclusion Criteria: * Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). * Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the ...
HLD100 is an investigational small molecule developed by Collegium Pharmaceutical, Inc. for Attention-Deficit Hyperactivity Disorder (ADHD). It is a delayed and extended release formulation of dextroamphetamine sulfate. It has been studied in a Phase 2 clinical trial in children with ADHD.
HLD100 is being developed for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). The only clinical trial of HLD100 to date enrolled children with ADHD. It is not approved for any indication and remains investigational.
HLD100 is being developed by Collegium Pharmaceutical, Inc., which trades on the Nasdaq under the ticker COLL. The company is the sponsor of the Phase 2 trial of HLD100 in children with ADHD.
HLD100 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The trial was a controlled study of a delayed and extended release formulation of dextroamphetamine sulfate in children with ADHD.
HLD100 has been studied in one completed Phase 2 trial, NCT02884544, titled A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD. The trial enrolled 22 participants in the United States and was controlled but not randomized or double-blind.
HLD100 is a delayed and extended release formulation of dextroamphetamine sulfate. Dextroamphetamine sulfate is the active ingredient, and HLD100 refers to the specific formulation developed by Collegium Pharmaceutical for ADHD.