CAB-LA Loading Dose — Competitive Intelligence Brief

CAB-LA Loading Dose (CAB-LA Loading Dose) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Integrase strand transfer inhibitor (INSTI). Area: Immunology / Infectious Disease.

phase 3 Integrase strand transfer inhibitor (INSTI) HIV integrase Immunology / Infectious Disease Small molecule

Target snapshot

CAB-LA Loading Dose (CAB-LA Loading Dose) — National Institute of Allergy and Infectious Diseases (NIAID). CAB-LA is a long-acting injectable formulation of cabotegravir, an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase to prevent viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
CAB-LA Loading Dose TARGET	CAB-LA Loading Dose	National Institute of Allergy and Infectious Diseases (NIAID)	phase 3	Integrase strand transfer inhibitor (INSTI)	HIV integrase
Antiretroviral/Anti HIV	Antiretroviral/Anti HIV	MSD Pharmaceuticals LLC	marketed	Antiretroviral agent (multiple classes: NRTI, NNRTI, PI, INSTI, entry inhibitor)	HIV reverse transcriptase, HIV protease, HIV integrase, CCR5, or CXCR4 (depending on specific agent)
Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Charlotte-Paige Rolle, MD	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
DTG/3TC/ABC + ELV/COBI/FTC/TAF	DTG/3TC/ABC + ELV/COBI/FTC/TAF	Fundacion SEIMC-GESIDA	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
Standard-of-care Antiretroviral therapy	Standard-of-care Antiretroviral therapy	Medical Research Council	marketed	Antiretroviral combination therapy (multiple classes: NRTI, NNRTI, PI, INSTI, entry inhibitors)	HIV reverse transcriptase, HIV protease, HIV integrase, HIV envelope glycoproteins (CCR5/CXCR4 co-receptors)
Biktarvy Tab	Biktarvy Tab	Southampton Healthcare, Inc.	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase, CCR5 co-receptor

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