Trial Profile

A pivotal trial of amphetamine (HLD-100) for the treatment of attention deficit hyperactivity disorder

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 12 Sep 2024

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At a glance

04 Sep 2024 According to Collegium Pharmaceutical media release, Ironshore Pharmaceutical and Development has been acquired and merged into Collegium Pharmaceutical.
12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, based on the results from HLD100-103 trial (see profile 276130), reviewed at an End of Phase 2 meeting with the FDA and based on the feedback company is pursuing for this and other pivotal trial (see profile 276138). These two pivotal trials will support of a New Drug Application with a differentiated label. Company intends to initiate the these trials in the third quarter of 2017, with a NDA expected in 2018.
15 Dec 2016 According to a Ironshore Pharmaceutical media release, company plans to initiate this study in 2017.

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