CAB-LA Maintenance Dose — Competitive Intelligence Brief

CAB-LA Maintenance Dose (CAB-LA Maintenance 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 Maintenance Dose (CAB-LA Maintenance 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 Maintenance Dose TARGET	CAB-LA Maintenance Dose	National Institute of Allergy and Infectious Diseases (NIAID)	phase 3	Integrase strand transfer inhibitor (INSTI)	HIV integrase
atazanavir/raltegravir	atazanavir/raltegravir	Community Research Initiative of New England	marketed	Antiretroviral combination (protease inhibitor + integrase inhibitor)	HIV protease and HIV integrase
raltegravir and atazanavir and ritonavir	raltegravir and atazanavir and ritonavir	Giovanni Di Perri	marketed	Antiretroviral combination therapy (INSTI + PI + booster)	HIV integrase, HIV protease
Different HAART regimens	Different HAART regimens	Danish HIV Research Group	marketed	Antiretroviral combination therapy	HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen composition)
Regimen：BIC+FTC+TAF	Regimen：BIC+FTC+TAF	National Center for AIDS/STD Control and Prevention, China CDC	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Genvoya Crushed Dose	Genvoya Crushed Dose	Johns Hopkins University	marketed	Antiretroviral combination (integrase inhibitor + NRTI + NtRTI + booster)	HIV integrase, HIV reverse transcriptase
efavirenz + emtricitabina + tenofovir	efavirenz + emtricitabina + tenofovir	Hospital Universitari Vall d'Hebron Research Institute	marketed	Antiretroviral combination therapy (NNRTI + NRTI + NtRTI)	HIV reverse transcriptase, HIV integrase

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