Sovaldi

PreclinicalSmall molecule

Sovaldi is one of 23 small molecule programs targeting Chronic Hepatitis C Virus Infection. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Chronic Hepatitis C Virus InfectionActive, not recruiting

Chronic Hepatitis C Virus InfectionPreclinical

Active, not recruiting

Competition

Competitive Landscape

22 competitors in Chronic Hepatitis C Virus Infection

#DrugCompanyPhaseTrials

Sovaldi

Gilead

Approved

7 2

Virazole

CConrado Roberto Hoffmann Filho

Approved

16 3

Tecentriq

Roche

Approved

1 4

Avastin

Roche

Approved

1 5

Avapro

Calciferol

Lescol

Neoral

Actigall

Nolvadex

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

Clinical

Trials by Indication[1]

ALD3 trials

A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)

Completed·GGenuine Research Center, Egypt·Phase 1·NCT02605798·24 enrolled

A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

Completed·GGenuine Research Center, Egypt·Phase 1·NCT03062423·36 enrolled

A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

Completed·GGenuine Research Center, Egypt·Phase 1·NCT02953535·36 enrolled

CAR1 trial

A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)

Completed·GGenuine Research Center, Egypt·Phase 1·NCT02491450·24 enrolled

Chronic Hepatitis C Virus Infection1 trial

Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Completed· Gilead logo

Gilead··NCT02783976·25 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 14, 2014

SOVALDI

NDA NDA204671

Mar 20, 2015

SOVALDI

NDA NDA204671

Aug 19, 2015

SOVALDI

NDA NDA204671

Feb 14, 2017

SOVALDI

NDA NDA204671

Apr 7, 2017

SOVALDI

NDA NDA204671

Nov 9, 2017

SOVALDI

NDA NDA204671

Oct 23, 2018

SOVALDI

NDA NDA204671

Aug 28, 2019

SOVALDI

NDA NDA204671

Aug 28, 2019

SOVALDI

NDA NDA212480

Sep 19, 2019

SOVALDI

NDA NDA204671

Dec 4, 2019

SOVALDI

NDA NDA212480

Mar 5, 2020

SOVALDI

NDA NDA204671

Mar 5, 2020

SOVALDI

NDA NDA212480

Aug 27, 2020

SOVALDI

NDA NDA204671

Dec 23, 2024

SOVALDI

NDA NDA204671

Dec 23, 2024

SOVALDI

NDA NDA212480

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Sovaldi. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sovaldi compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sovaldi. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA204671). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: Gilead

Sovaldi

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

ALD3 trials

CAR1 trial

Chronic Hepatitis C Virus Infection1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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