Numerous clinical trials evaluate the therapeutic efficacy, safety, and pharmacokinetics of favipiravir across Phase 1 through Phase 4 studies for conditions including COVID-19, human influenza, Lassa fever, Crimean-Congo hemorrhagic fever, and hepatic impairment, alongside evaluations in healthy volunteers. Sponsored by academic, governmental, and commercial entities—such as the Institut National de la Sante Et de la Recherche Medicale, the Liverpool School of Tropical Medicine, and FUJIFILM Toyama Chemical Co. Ltd.—this global research portfolio encompasses actively recruiting, completed, and terminated studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06860334 | RECRUITING | Crimean-Congo Hemorrhagic Fever |
Liverpool School of Tropical Medicine |
2026-06-04 | PHASE2 |
| NCT06024421 | RECRUITING | Infectious Disease; Pharmacology |
Institut National de la Santé Et de la Recherche Médicale, France |
2024-05-14 | PHASE1 |
| NCT06212336 | RECRUITING | Lassa Fever |
Irrua Specialist Teaching Hospital |
2025-05-02 | PHASE2; PHASE3 |
| NCT04746183 | RECRUITING | Covid19 |
University of Liverpool |
2020-07-03 | PHASE1; PHASE2 |
| NCT05648448 | RECRUITING | Influenza; Influenza, Human |
University of Oxford |
2023-02-22 | PHASE2 |
| NCT06488300 | RECRUITING | Respiratory Syncytial Virus; Respiratory Syncytial Virus, Human |
University of Oxford |
2024-07-25 | PHASE2 |
| NCT05041907 | RECRUITING | COVID-19 |
University of Oxford |
2021-09-30 | PHASE2 |
| NCT06024421 | Recruiting | Infectious Disease|Pharmacology |
Institut National de la Santé Et de la Recherche Médicale France|FUJIFILM Toyama Chemical Co. Ltd. |
2024-04 | Phase 1 |
| NCT05940545 | UNKNOWN | CCHF |
Liverpool School of Tropical Medicine |
2023-07-12 | PHASE1; PHASE2 |
| NCT05940545 | Recruiting | CCHF |
Liverpool School of Tropical Medicine |
2023-07-12 | Phase 1|Phase 2 |
| NCT04918927 | COMPLETED | Covid19 |
Coordinación de Investigación en Salud, Mexico |
2021-10-12 | PHASE2 |
| NCT04784559 | TERMINATED | COVID-19 Infection |
PharmaMar |
2021-06-04 | PHASE3 |
| NCT05502081 | COMPLETED | COVID-19 |
Mansoura University Hospital |
2022-09-02 | PHASE4 |
| NCT05279235 | TERMINATED | Moderate to Severe COVID-19 |
Shanghai Vinnerna Biosciences Co., Ltd. |
2022-03-14 | PHASE3 |
| NCT04907682 | COMPLETED | Lassa Fever |
Bernhard Nocht Institute for Tropical Medicine |
2021-07-30 | PHASE2 |
| NCT05155527 | UNKNOWN | COVID-19 |
Mahidol University |
2022-02-10 | PHASE2 |
| NCT04718285 | UNKNOWN | COVID-19; SARS-CoV-2 |
Bahçeşehir University |
2021-05-15 | PHASE2 |
| NCT04475991 | TERMINATED | COVID-19 |
Hospital General de México Dr. Eduardo Liceaga |
2021-07-13 | PHASE2 |
| NCT05185284 | COMPLETED | COVID-19 |
Promomed, LLC |
2021-08-11 | PHASE3 |
| NCT05417997 | COMPLETED | COVID-19 Respiratory Infection; FLU; Cold; Influenza; Bacterial Pneumonia; COVID-19 Pneumonia |
RAAS Nutritionals, LLC |
2021-05-29 | PHASE3 |
| NCT04499677 | COMPLETED | COVID-19 |
University College, London |
2020-09-24 | PHASE2 |
| NCT04940871 | TERMINATED | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) |
University of Pecs |
2021-11-25 | PHASE2 |
| NCT04445467 | UNKNOWN | COVID |
Bayside Health |
2020-07-30 | PHASE2 |
| NCT04448119 | TERMINATED | COVID-19; SARS-CoV-2 |
Appili Therapeutics Inc. |
2020-10-16 | PHASE2 |
| NCT04613271 | COMPLETED | Infectious Disease; SARS-CoV Infection; Covid19 |
Ina-Respond |
2020-10-15 | PHASE3 |
| NCT04600895 | COMPLETED | Covid19 |
Appili Therapeutics Inc. |
2020-11-30 | PHASE3 |
| NCT04828564 | UNKNOWN | SARS-CoV2; COVID-19 |
The Scientific and Technological Research Council of Turkey |
2021-04 | PHASE2; PHASE3 |
| NCT05014373 | UNKNOWN | Covid19 |
University of the Philippines |
2020-10-12 | PHASE3 |
| NCT04303299 | COMPLETED | SARS-COV-2 Infections; COVID-19 |
Department of Medical Services Ministry of Public Health of Thailand |
2020-08-19 | PHASE3 |
| NCT04532931 | COMPLETED | COVID-19 |
Shin Poong Pharmaceutical Co. Ltd. |
2020-09-03 | PHASE2 |
| NCT04464408 | COMPLETED | COVID-19 |
King Abdullah International Medical Research Center |
2020-07-23 | PHASE2; PHASE3 |
| NCT04818320 | COMPLETED | Covid19 |
Penang Hospital, Malaysia |
2021-02-16 | PHASE3 |
| NCT04907682 | Completed | Lassa Fever |
Bernhard Nocht Institute for Tropical Medicine|University of Hamburg-Eppendorf|Alliance for International Medical Action|Institut National de la Santé Et de la Recherche Médicale France|University of Bordeaux|Federal Medical Centre Owo|Irrua Specialist Teaching Hospital |
2021-07-30 | Phase 2 |
| NCT04373733 | COMPLETED | Coronavirus Infection |
Chelsea and Westminster NHS Foundation Trust |
2020-05-01 | PHASE3 |
| NCT04346628 | COMPLETED | Sars-CoV2; COVID-19 |
Stanford University |
2020-07-12 | PHASE2 |
| NCT04694612 | UNKNOWN | Covid19 |
Nepal Health Research Council |
2021-01-01 | PHASE3 |
| NCT04387760 | COMPLETED | SARS-CoV 2; COVID-19 |
Royal College of Surgeons in Ireland - Medical University of Bahrain |
2020-08-11 | PHASE2 |
| NCT04981379 | COMPLETED | Covid19 |
Health Institutes of Turkey |
2020-11-16 | PHASE3 |
| NCT04392973 | COMPLETED | COVID19 |
King Abdullah International Medical Research Center |
2020-05-21 | |
| NCT04529499 | TERMINATED | Covid19 |
Dr. Reddy's Laboratories Limited |
2020-08-22 | PHASE3 |
| NCT04411433 | UNKNOWN | Sars-CoV2; COVID-19 |
Ministry of Health, Turkey |
2020-05-08 | PHASE3 |
| NCT04600999 | COMPLETED | SARS-CoV-2 Infection |
University of Pecs |
2020-10-07 | PHASE3 |
| NCT04558463 | UNKNOWN | Covid19 |
Indonesia University |
2020-04-16 | PHASE3 |
| NCT04358549 | COMPLETED | COVID-19 |
Fujifilm Pharmaceuticals U.S.A., Inc. |
2020-04-17 | PHASE2 |
| NCT04351295 | COMPLETED | COVID |
Tanta University |
2020-04-20 | PHASE2; PHASE3 |
| NCT04478448 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2020-08-13 | PHASE1 |
| NCT04542694 | COMPLETED | COVID-19 |
Promomed, LLC |
2020-05-21 | PHASE3 |
| NCT04425460 | UNKNOWN | COVID-19 |
Zhejiang Hisun Pharmaceutical Co. Ltd. |
2020-06 | PHASE3 |
| NCT04501783 | COMPLETED | COVID-19 |
R-Pharm |
2020-05-20 | PHASE3 |
| NCT04407000 | COMPLETED | Bioequivalence |
World Medicine ILAC SAN. ve TIC. A.S. |
2020-06-23 | PHASE1 |
| NCT04402203 | UNKNOWN | COVID-19; Favipiravir (Favipira) |
Bangladesh Medical Research Council (BMRC) |
2020-05 | PHASE2; PHASE3 |
| NCT04434248 | UNKNOWN | COVID-19 |
Chromis LLC |
2020-04-23 | PHASE2; PHASE3 |
| NCT04336904 | UNKNOWN | COVID-19 |
Giuliano Rizzardini |
2020-03-25 | PHASE3 |
| NCT04349241 | COMPLETED | Coronavirus Disease (COVID-19) |
Ain Shams University |
2020-04-18 | PHASE3 |
| NCT04333589 | UNKNOWN | COVID-19 |
Peking University First Hospital |
2020-04-01 | |
| NCT04359615 | UNKNOWN | COVID-19 |
Shahid Beheshti University of Medical Sciences |
2020-04-20 | PHASE4 |
| NCT04310228 | UNKNOWN | COVID-19 |
Peking University First Hospital |
2020-03-08 | |
| NCT04319900 | UNKNOWN | Novel Coronavirus Pnuemonia |
Beijing Chao Yang Hospital |
2020-03-05 | PHASE2; PHASE3 |
| NCT04376814 | COMPLETED | COVID-19; Favipiravir; Kaletra; Hydroxychloroquine; Lopinavir/Ritonavir |
Baqiyatallah Medical Sciences University |
2020-03-29 | |
| NCT03394209 | COMPLETED | Influenza, Human; Critical Illness; Influenza |
Capital Medical University |
2018-02-06 | PHASE2 |
| NCT02739477 | TERMINATED | Ebola Virus Survivor |
Institut National de la Santé Et de la Recherche Médicale, France |
2016-04 | PHASE2 |
| NCT02329054 | COMPLETED | Ebola Virus Disease |
Institut National de la Santé Et de la Recherche Médicale, France |
2014-12 | PHASE2 |
| NCT02662855 | COMPLETED | Ebola Virus Disease |
Beijing Institute of Pharmacology and Toxicology |
2014-11 | PHASE2 |
| NCT02026349 | COMPLETED | Influenza |
MDVI, LLC |
2014-01 | PHASE3 |
| NCT02008344 | COMPLETED | Influenza |
MDVI, LLC |
2013-12 | PHASE3 |
| NCT01419457 | COMPLETED | Healthy; Hepatic Impairment |
MDVI, LLC |
2011-08 | PHASE1 |
| NCT01728753 | COMPLETED | Influenza |
MDVI, LLC |
2012-11 | PHASE1; PHASE2 |
| NCT01068912 | COMPLETED | Influenza |
MDVI, LLC |
2010-02 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-07)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Favipiravir (T-705) Solubility in DMSO
- Favipiravir (T-705) Stock Solution
- Favipiravir (T-705) Storage
- Favipiravir (T-705) Stability
- Favipiravir (T-705) Molecular Weight
- Favipiravir (T-705) SMILES
- Favipiravir (T-705) CAS Number
- Favipiravir (T-705) Chemical Structure (2D and 3D)
- Favipiravir (T-705) SDS|MSDS