NOVATEK PHARMACEUTICALS

Novatek Pharmaceuticals Initiates A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study Of Its Oral Drug, TQ Formula, Against Novel Coronavirus 2019 (COVID-19) In The Outpatient Setting

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Friday, August 13, 2021
Coronaviridae, RT-PCR, Thymoquinone, Cros, INC, Coronavirus, Șaeș, Nigella, Patient, COVID-19, IND, Nigella sativa, GMP, Capsule, FDA, BID, Severe acute respiratory syndrome coronavirus 2, Safety, TQ, Pharmaceutical industry

HOUSTON, Aug. 12, 2021 /PRNewswire/ -- Novatek Pharmaceuticals, INC announced today that the company received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient setting.

Key Points: 
  • HOUSTON, Aug. 12, 2021 /PRNewswire/ -- Novatek Pharmaceuticals, INC announced today that the company received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient setting.
  • The study is currently enrolling patients, with 16 out of 60 patients already randomized with no reported serious adverse events (SAEs) reported, to-date.
  • This is a randomized, double-blind, placebo-controlled phase II study where participants will be randomized 1:1 and will receive up to 14 days of oral dosing.
  • TQ Formula is an oral GMP-manufactured drug, which represents a concentrated enteric-coated formulation of Nigella Sativa oil, with higher than average thymoquinone concentration.