Trial Profile
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects with Chronic Kidney Disease and Metabolic Acidosis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 25 Jun 2021
Price :
$35
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At a glance
- Drugs Veverimer (Primary)
- Indications Metabolic acidosis; Renal failure
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Tricida
- 10 Feb 2021 According to a Zhang Investor Law media release, a class action lawsuit has been filled on behalf of shareholders of Tricida. According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that, Tricida's NDA for veverimer was materially deficient; accordingly, it was foreseeably likely that the FDA would not accept the NDA for veverimer; and hence, the Company's public statements were materially false and misleading.
- 08 Dec 2020 'According to a Tricida media release, if accepted for consideration, a decision on the FDRR is expected in the first quarter of 2021. The timing and next steps for a resubmission of the NDA for veverimer will be dependent upon the OND's decision.
- 08 Dec 2020 According to a Tricida media release, a Formal Dispute Resolution Request (FDRR) has been submitted to the FDA to seek clarity on resubmitting NDA through the Accelerated Approval Program. The FDRR requests that the Office of New Drugs (OND) find that the magnitude of serum bicarbonate change seen in the TRCA-301 and TRCA-301E trials to predict clinical benefit in the treatment of metabolic acidosis associated with CKD and that it can therefore serve as the basis for accelerated approval.