dexmedetomidine patch (TPU-006) / Teikoku - LARVOL DELTA

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Teikoku Pharma USA, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Jan 2027 | Trial primary completion date: Dec 2024 ➔ Jan 2027

Enrollment open • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia

DMT2111: Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty (clinicaltrials.gov) - P2 | N=179 | Terminated | Sponsor: Teikoku Pharma USA, Inc. | Recruiting ➔ Terminated; The SMC recommended stopping the trial. hemodynamic effects.

Trial termination • Aesthetic Medicine • Pain

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Teikoku Pharma USA, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia

Teikoku Pharma USA announces positive topline results from Phase 2 clinical trial of TPU-006, non- opioid pain management patch in Abdominoplasty Surgery. (Canada Newswire) - P2 | N=182 | NCT05412992 | Sponsor: Teikoku Pharma USA, Inc. | "Teikoku Pharma USA...announced positive topline results from its Phase 2 proof of concept study of TPU-006, a 4-day dexmedetomidine transdermal patch for Post Surgical Pain....The new analysis shows that treatment with TPU-006 resulted in statistically significantly lower pain scores and reduced use of opioid rescue medication compared with placebo. TPU-006 was well tolerated with no unexpected adverse events, little application site skin irritation, and minimal drowsiness. Patients treated with TPU-006 experienced less constipation and nausea likely due to reduced use of opioid rescue medication."

P2 data • CNS Disorders • Pain

Teikoku Pharma granted FDA Fast Track Designation for TPU-006, a Novel 4-day Dexmedetomidine Transdermal System for Post Operative Pain Management (Canada Newswire) - "Teikoku Pharma USA...announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TPU-006 in managing postoperative pain. TPU-006 is an investigational 4-day dexmedetomidine transdermal system, a novel drug delivery technology with a non-opioid active moiety for managing post-surgical pain....TPU-006's evaluation involves a randomized, double-blind Phase 2b clinical trial in patients undergoing abdominoplasty to examine this agent's efficacy and safety. The Company expects results from this study in the third quarter of 2023."

Fast track designation • P2b data • CNS Disorders • Pain

DMT2111: Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty (clinicaltrials.gov) - P2 | N=182 | Recruiting | Sponsor: Teikoku Pharma USA, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Aesthetic Medicine • Pain

DMT2111: Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty (clinicaltrials.gov) - P2 | N=182 | Not yet recruiting | Sponsor: Teikoku Pharma USA, Inc.

New P2 trial • Aesthetic Medicine • Pain

Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty (clinicaltrials.gov) - P2; N=164; Recruiting; Sponsor: Teikoku Pharma USA, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Aesthetic Medicine • Anesthesia • Pain

Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty (clinicaltrials.gov) - P2; N=164; Not yet recruiting; Sponsor: Teikoku Pharma USA, Inc.

Clinical • New P2 trial