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RdRp is an attractive target for developing therapies for COVID-19 as it plays a crucial role in the replication of SARS-CoV-2 (Scheme 1) and is well conserved between coronaviruses (RNA viruses).
Drug’s Name | Dosage Forms (Route/Dose) |
Indications (Marketing Status) |
Countries |
---|---|---|---|
Remdesivir (Veklury®) |
Solution/Powder (Intravenous/200 mg loading dose, followed by 100 mg once daily for 5 to 10 days for adults) |
COVID-19 patients of ≥12 years requiring hospitalization (Prescription) |
Approved in >50 countries including USA, KSA, UAE and European Union |
Favipiravir (FabiFlu®) |
Film-coated tablet (Oral/1800 mg/dose twice a day on the first day; followed by 800 mg/dose twice a day for 7–10 days for adults) |
COVID-19 (Prescription) |
Approved in many countries, including China, India, Russia and Japan |
Type of Study | Total Participants | Dose | Pharmacokinetic Data |
---|---|---|---|
Interventional, phase 1, randomized, double-blind, placebo-controlled study | 130 | (i) A total of 64 subjects received a single oral dose of 50 to 1600 mg molnupiravir or placebo in the single-ascending-dose part. | Mean Cmax up to 13.2 ng/mL and median tmax 0.25 and 0.75 h for doses in between 600–1600 mg. Excretion in urine (0.002%) for >800 mg dose. Geometric mean terminal elimination half-lives (t1/2) = 0.91–1.29 h postdose of drug up to 800 mg dose. Median t1/2 for 1200 and 1600 mg doses = 1.75 and 1.50 h |
(ii) A total of 55 subjects received twice-daily (BID) doses of 50 to 800 mg molnupiravir or placebo for 5.5 days in the multiple-ascending-dose part. | Median tmax in all dose cohorts of between 1.00 and 1.75 h postdose across both Days 1 and 6. At the 800-mg BID dose level, the mean t1/2 = 7.08 h AUCτ = 0.938–1.16; Cmax= 0.843–1.10 at all dose levels |
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(iii) A total of 10 subjects received a single dose of 200 mg in the fed state followed by a single dose of 200 mg molnupiravir in the fasted state after a washout period of 14 days, or vice versa. | Mean Cmax—approximately 36% lower in the fed state compared to the fasted state AUCinf—similar for both fed and fasted states Mean t1/2 in fed and fasted treatments = 1.09 and 0.977 h |
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(iv) One subject in the multiple-ascending-dose part received 800 mg molnupiravir BID for three days. | It was discontinued by the investigators. |
Sponsor (Status) |
Phase (Number Enrolled) (Interventions) |
NCT Number (Other IDs) |
Start Date (SD)/Completion Date (CD)/Last Update (LU) |
---|---|---|---|
Merck Sharp & Dohme Corp. (Active, not recruiting) |
2/3 (304) (Molnupiravir/Placebo) |
NCT04575584 (4482-001, 2020-003367-26, MK-4482-001, PHRR201210-003189, jRCT2031200404) |
SD: 19 October 2020 CD: 10 August 2021 LU: 7 May 2021 |
Merck Sharp & Dohme Corp.(Recruiting) | 2/3 (1850) (Molnupiravir/Placebo) |
NCT04575597 (4482-002, 2020-003368-24, MK-4482-002, PHRR201209-003186, RCT2031210148) |
SD: 19 October 2020 CD: 19 April 2022 LU: 5 August 2021 |
Merck Sharp & Dohme Corp. (Not yet recruiting) |
3 (1332) (Molnupiravir/Placebo) |
NCT04939428 (4482-013, 2021-000904-39, MK-4482-013) |
SD: 16 August 2021 CD: 3 April 2022 LU: 4 August 2021 |
Ridgeback Biotherapeutics (Recruiting) |
2 (96) (EIDD-2801/Placebo) |
NCT04405739 (EIDD-2801-2004) |
SD: 16 June 2020 CD: 8 December 2021 LU: 20 May 2021 |
Ridgeback Biotherapeutics (Completed) |
1 (130) (EIDD-2801/Placebo) |
NCT04392219 (EIDD-2801-1001, 2020-001407-17) |
SD: 10 April 2020 CD: 11 August 2020 LU: 19 July 2021 |
Ridgeback Biotherapeutics (Completed) |
2 (204) (EIDD-2801/Placebo) |
NCT04405570 (EIDD-2801-2003) |
SD: 16 June 2020 CD: 21 February 2021 LU: 23 February 2021 |
University of Liverpool (Recruiting) |
1/2 (600) (EIDD-2801/Nitazoxanide/VIR-7832/VIR-7831/Placebo) |
NCT04746183 (UoL001542) |
SD: 3 July 2020 CD: 30 April 2022 LU: 20 May 2021 |