Direct-acting antiviral therapy — Competitive Intelligence Brief

Direct-acting antiviral therapy (Direct-acting antiviral therapy) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral. Area: Infectious Disease.

phase 2 Direct-acting antiviral Viral enzymes Infectious Disease Small molecule

Target snapshot

Direct-acting antiviral therapy (Direct-acting antiviral therapy) — Hospices Civils de Lyon. Direct-acting antiviral therapy targets viral replication by inhibiting viral enzymes.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Direct-acting antiviral therapy TARGET	Direct-acting antiviral therapy	Hospices Civils de Lyon	phase 2	Direct-acting antiviral	Viral enzymes
Ledipasvir and sofosbuvir	Ledipasvir and sofosbuvir	National Taiwan University Hospital	marketed	Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor)	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
Epclusa (SOF/VEL)	Epclusa (SOF/VEL)	University of California, San Francisco	marketed	Direct-acting antiviral combination (nucleotide + non-nucleoside polymerase inhibitor)	HCV NS5B RNA-dependent RNA polymerase
Grazaoprevir/Elbasavir/RBV	Grazaoprevir/Elbasavir/RBV	The HIV Netherlands Australia Thailand Research Collaboration	marketed	Direct-acting antiviral (DAA) combination; NS3/4A protease inhibitor + NS5A inhibitor + nucleoside analog	HCV NS3/4A protease; HCV NS5A protein; viral RNA polymerase
Grazoprevir/Elbasvir	Grazoprevir/Elbasvir	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba	marketed	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease and NS5A protein
sofosbuvir/velpatasvir crushed	sofosbuvir/velpatasvir crushed	Radboud University Medical Center	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
EBR/GZR	EBR/GZR	Dallas VA Medical Center	marketed	Direct-acting antiviral combination (NS5A inhibitor + NS3/4A protease inhibitor)	Hepatitis C virus NS5A protein and NS3/4A serine protease

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Direct-acting antiviral class)

1. Hospices Civils de Lyon · 1 drug in this class
2. Iran Hepatitis Network · 1 drug in this class
3. Qing XIe · 1 drug in this class
4. Sang Gyune Kim · 1 drug in this class