Trial Profile

A clinical trial evaluating PK/PD of otenaproxesul in healthy volunteers

Status: Suspended

Phase of Trial: Phase I

Latest Information Update: 08 Apr 2024

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At a glance

Drugs Otenaproxesul (Primary)
Indications Acute pain
Focus First in man; Pharmacodynamics; Pharmacokinetics
Sponsors Antibe Therapeutics

Most Recent Events

01 Apr 2024 According to an Antibe Therapeutics media release, company announced that it received verbal notice on March 28, 2024 from the U.S. Food and Drug Administration (FDA) that otenaproxesul has been placed on clinical hold. Antibe expects to receive a formal Clinical Hold Letter from the FDA within 30 days outlining their rationale and further details.
01 Apr 2024 Status changed to suspended, according to an Antibe Therapeutics media release
19 Oct 2023 According to an Antibe Therapeutics media release, data in November will inform Phase II trial expected to launch in Q1 2024.

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