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Avigan

(Favipiravir)

Phase 3Small molecule

AAppili Therapeutics Inc.

Favipiravir is an antiviral medication used to treat certain viral infections, particularly influenza and has been investigated for use against other viruses like COVID-19. It works by interfering with the virus's ability to reproduce in the body.[1] Avigan is currently being investigated across 8 indications[3], with its most advanced program in Phase 3.[1]

Avigan is one of 157 small molecule programs targeting Viral Pneumonia. It is currently in Phase 3.

8

Indications

56

Total Trials

7

Active Trials

156

Competitors

Pipeline

Status by Indication[3][1]

Indication

Viral PneumoniaActive, not recruiting

Viral DiseaseUnknown

VirusUnknown status

TreatmentRecruiting

InfluenzaCompleted

Lassa FeverRecruiting

COVID-19Unknown status

ToleranceTerminated

Viral PneumoniaPreclinical

Active, not recruiting

Viral DiseasePreclinical

Unknown

VirusPreclinical

Unknown status

TreatmentPhase 2

Recruiting

InfluenzaPhase 2

Completed

Lassa FeverPhase 3

Recruiting

COVID-19Phase 3

Unknown status

TolerancePhase 2

Terminated

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Avigan

AAppili Therapeutics Inc.

Dexilant

Alfenta

Jazz Pharmaceuticals

Niclocide

Hivid

CConrado Roberto Hoffmann Filho

Valium

Akero Therapeutics

Lotemax

Norpramin

VValidus Pharmaceuticals

Barhemsys

Tibotec Pharmaceuticals, Ireland

Clomid

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

COVID-19

NCT05041907

Phase 2Recruiting

Treatment

NCT06488300

Phase 2Recruiting

Influenza

NCT05648448

Q2 2027

Phase 2/3Recruiting

Lassa Fever

NCT06212336

Q4 2027

Phase 1Recruiting

Tolerance

NCT06024421

Q3 2028

Phase 2Recruiting

Hemorrhagic Fever

NCT06860334

Clinical

Trials by Indication[1]

COVID-1933 trials

Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection

Terminated·PPharmaMar·Phase 3·NCT04784559·205 enrolled

The Prevent Severe COVID-19 (PRESECO) Study

Completed·AAppili Therapeutics Inc.·Phase 3·NCT04600895·1,187 enrolled

Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19

Unknown status·TThe Scientific and Technological Research Council of Turkey·Phase 2/3·NCT04828564·100 enrolled

Show 30 more trials

Favipiravir in High-risk COVID-19 Patients

Completed·PPenang Hospital, Malaysia·Phase 3·NCT04818320·500 enrolled

Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19

Completed·—·N/A·NCT04376814·40 enrolled

Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients

Completed·MMansoura University Hospital·Phase 4·NCT05502081·265 enrolled

Clinical Study To Evaluate The Performance And Safety Of Favipiravir in COVID-19

Unknown status·GGiuliano Rizzardini·Phase 3·NCT04336904·100 enrolled

The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19

Unknown status·IIndonesia University·Phase 3·NCT04558463·100 enrolled

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Recruiting·UUniversity of Oxford·Phase 2·NCT05041907·3,800 enrolled

AGILE (Early Phase Platform Trial for COVID-19)

Recruiting·UUniversity of Liverpool·Phase 1/2·NCT04746183·600 enrolled

Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19

Completed·FFujifilm Pharmaceuticals U.S.A., Inc.·Phase 2·NCT04358549·50 enrolled

Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment

Completed·HHealth Institutes of Turkey·Phase 3·NCT04981379·1,120 enrolled

Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19

Completed·PPromomed, LLC·Phase 3·NCT05185284·217 enrolled

Clinical Trial of Favipiravir Treatment of Patients With COVID-19

Completed·UUniversity of Pecs·Phase 3·NCT04600999·14 enrolled

Control of COVID-19 Outbreaks in Long Term Care

Terminated·AAppili Therapeutics Inc.·Phase 2·NCT04448119·67 enrolled

Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age

Unknown status·MMinistry of Health, Turkey··NCT04474457·1,000 enrolled

Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19

Completed·RR-Pharm·Phase 3·NCT04501783·168 enrolled

Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh

Unknown status·BBangladesh Medical Research Council (BMRC)·Phase 2/3·NCT04402203·50 enrolled

Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19

Completed·PPromomed, LLC·Phase 3·NCT04542694·200 enrolled

Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

Completed·IIna-Respond·Phase 3·NCT04613271·130 enrolled

Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19

Completed·SStanford University·Phase 2·NCT04346628·149 enrolled

Favipiravir in Hospitalized COVID-19 Patients

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 4·NCT04359615·40 enrolled

Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 2·NCT04918927·120 enrolled

Favipiravir vs Hydroxychloroquine vs Control in COVID -19

Completed·RRoyal College of Surgeons in Ireland - Medical University of Bahrain·Phase 2·NCT04387760·150 enrolled

Favipiravir Therapy in Adults With Mild COVID-19

Completed·KKing Abdullah International Medical Research Center·Phase 2/3·NCT04464408·231 enrolled

An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

Unknown status·BBayside Health·Phase 2·NCT04445467·190 enrolled

Efficacy of Faviprevir in COVID-19 Treatment

Completed·TTanta University·Phase 2/3·NCT04351295·92 enrolled

Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients

Completed·RRAAS Nutritionals, LLC·Phase 3·NCT05417997·71 enrolled

Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal

Unknown status·NNepal Health Research Council·Phase 3·NCT04694612·676 enrolled

Early Intervention in COVID-19: Favipiravir Verses Standard Care

Completed·CChelsea and Westminster NHS Foundation Trust·Phase 3·NCT04373733·502 enrolled

An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19

Unknown status·CChromis LLC·Phase 2/3·NCT04434248·330 enrolled

Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19

Unknown status·MMinistry of Health, Turkey·Phase 3·NCT04411433·1,008 enrolled

Efficacy and Safety of Favipiravir in Management of COVID-19

Completed·—·Phase 3·NCT04349241·100 enrolled

Influenza6 trials

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316

Completed·MMDVI, LLC·Phase 3·NCT02026349·860 enrolled

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

Completed·MMDVI, LLC·Phase 3·NCT02008344·1,161 enrolled

T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza

Completed·MMDVI, LLC·Phase 1/2·NCT01728753·550 enrolled

Show 3 more trials

A Pharmacokinetics Study of Favipiravir in Patients With Severe Influenza

Completed·—·Phase 2·NCT03394209·34 enrolled

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Recruiting·UUniversity of Oxford·Phase 2·NCT05648448·3,000 enrolled

Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

Completed·MMDVI, LLC·Phase 2·NCT01068912·530 enrolled

Treatment2 trials

UMIT-1 Trial Favipiravir & Ribavirin for the Treatment of CCHF

Unknown status·LLiverpool School of Tropical Medicine·Phase 1/2·NCT05940545·24 enrolled

Assessing Antiviral Treatments in Early Symptomatic RSV

Recruiting·UUniversity of Oxford·Phase 2·NCT06488300·1,000 enrolled

Lassa fever2 trials

Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever

Completed·BBernhard Nocht Institute for Tropical Medicine·Phase 2·NCT04907682·40 enrolled

ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

Recruiting·IIrrua Specialist Teaching Hospital·Phase 2/3·NCT06212336·1,755 enrolled

Tolerance2 trials

Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers

Recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 1·NCT06024421·39 enrolled

Tolerance and Activity Evaluation of High Doses of Favipiravir Against Ebola Virus in the Semen

Terminated·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 2·NCT02739477·2 enrolled

11 more indications

Efficacy and Safety1 trial

Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

Terminated·SShanghai Vinnerna Biosciences Co., Ltd.·Phase 3·NCT05279235·290 enrolled

Tocilizumab1 trial

Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019

Unknown status·PPeking University First Hospital·N/A·NCT04310228·150 enrolled

Double-blind1 trial

A Multi-center,Randomized,Double-blind,Placebo-controlled,Phase 3 Study Evaluating Favipiravir in Treatment of COVID19

Unknown status·ZZhejiang Hisun Pharmaceutical Co. Ltd.·Phase 3·NCT04425460·256 enrolled

ALS1 trial

FLARE: Favipiravir +/- Lopinavir: A RCT of Early Antivirals

Completed·UUniversity College, London·Phase 2·NCT04499677·240 enrolled

Efficacy1 trial

Efficacy of Favipiravir Against Ebola (JIKI)

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 2·NCT02329054·126 enrolled

Hepatic Impairment1 trial

Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Completed·MMDVI, LLC·Phase 1·NCT01419457·36 enrolled

Virus1 trial

Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

Unknown status·PPeking University First Hospital·N/A·NCT04333589·210 enrolled

Ebola Virus Disease1 trial

Efficacy of Favipiravir Against Severe Ebola Virus Disease

Completed·—·Phase 2·NCT02662855·77 enrolled

Antiviral Drug1 trial

Antiviral Drugs on the Treatment of SARS-CoV-2

Completed·—··NCT04727775·150 enrolled

Pneumonia1 trial

Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

Unknown status·—·Phase 2/3·NCT04319900·150 enrolled

Hemorrhagic Fever1 trial

UMIT-2: A Randomized, Multi-country, Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for Crimean-Congo Haemorrhagic Fever

Recruiting·LLiverpool School of Tropical Medicine·Phase 2·NCT06860334·378 enrolled

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Favipiravir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Favipiravir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Favipiravir. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Appili Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RNA-Directed RNA Polymerase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAppili Therapeutics Inc.

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