APRETUDE (cabotegravir) — Competitive Intelligence Brief

APRETUDE (cabotegravir) (APRETUDE (cabotegravir)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Integrase strand transfer inhibitor (INSTI). Area: Infectious Disease / Virology.

marketed Integrase strand transfer inhibitor (INSTI) HIV integrase Infectious Disease / Virology Small molecule

Target snapshot

APRETUDE (cabotegravir) (APRETUDE (cabotegravir)) — Massachusetts General Hospital. Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
APRETUDE (cabotegravir) TARGET	APRETUDE (cabotegravir)	Massachusetts General Hospital	marketed	Integrase strand transfer inhibitor (INSTI)	HIV integrase
bictegravir/emtricitabine/tenofovir alafenamide	bictegravir/emtricitabine/tenofovir alafenamide	Midland Research Group, Inc.	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
TDF/3TC/EFV or DTG or NVP	TDF/3TC/EFV or DTG or NVP	MU-JHU CARE	marketed	Antiretroviral combination therapy (NRTI + NNRTI or INSTI)	HIV reverse transcriptase, HIV integrase
elvitegravir/cobicistat/emtricitabine/tenofovir	elvitegravir/cobicistat/emtricitabine/tenofovir	Juan A. Arnaiz	marketed	Antiretroviral combination (INSTI + pharmacokinetic booster + NRTIs)	HIV integrase, CYP3A4, HIV reverse transcriptase
CAR	CAR	ViiV Healthcare	marketed	Antiretroviral combination therapy (INSTI + NNRTI)	HIV integrase and HIV reverse transcriptase
Raltegravir, tenofovir/emtricitabine	Raltegravir, tenofovir/emtricitabine	University of California, San Francisco	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
BIC/FTC/TAF	BIC/FTC/TAF	Prism Health North Texas	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase

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 (Integrase strand transfer inhibitor (INSTI) class)

1. ViiV Healthcare · 12 drugs in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 5 drugs in this class
3. Merck Sharp & Dohme LLC · 5 drugs in this class
4. Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · 1 drug in this class
5. Germans Trias i Pujol Hospital · 1 drug in this class
6. Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux · 1 drug in this class
7. ANRS, Emerging Infectious Diseases · 1 drug in this class
8. Massachusetts General Hospital · 1 drug in this class
9. University of Colorado, Denver · 1 drug in this class
10. MU-JHU CARE · 1 drug in this class