TMC125 — Competitive Intelligence Brief

TMC125 (TMC125) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Non-nucleoside reverse transcriptase inhibitor (NNRTI). Area: Infectious Disease.

phase 3 Non-nucleoside reverse transcriptase inhibitor (NNRTI) Reverse transcriptase Infectious Disease Small molecule

Target snapshot

TMC125 (TMC125) — Tibotec Pharmaceuticals, Ireland. TMC125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
TMC125 TARGET	TMC125	Tibotec Pharmaceuticals, Ireland	phase 3	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	Reverse transcriptase
Darunavir, Ritonavir, Truvada	Darunavir, Ritonavir, Truvada	Imperial College London	marketed	Antiretroviral combination therapy (protease inhibitor + reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase, CYP3A4
Adefor dipivoxil	Adefor dipivoxil	GlaxoSmithKline	marketed	Nucleotide reverse transcriptase inhibitor	Hepatitis B virus reverse transcriptase
emtricitabine, darunavir/cobicistat, maraviroc	emtricitabine, darunavir/cobicistat, maraviroc	Giovanni Di Perri	marketed	Antiretroviral combination (NRTI + PI + pharmacokinetic booster + CCR5 antagonist)	HIV reverse transcriptase, HIV protease, CYP3A4, CCR5 co-receptor
Antiretroviral therapy plus Interleukin-2	Antiretroviral therapy plus Interleukin-2	Juan A. Arnaiz	marketed	Combination immunotherapy and antiviral	HIV reverse transcriptase, protease, integrase (ART component); IL-2 receptor (IL-2 component)
Entecavir + Fuzheng Huayu Tablet	Entecavir + Fuzheng Huayu Tablet	ShuGuang Hospital	marketed	Nucleoside reverse transcriptase inhibitor (entecavir component); traditional Chinese medicine formulation (Fuzheng Huayu component)	HBV polymerase/reverse transcriptase (entecavir); multiple targets including hepatic stellate cells and inflammatory pathways (Fuzheng Huayu)
Standard Triple	Standard Triple	University of Alberta	marketed	Antiretroviral combination therapy	HIV reverse transcriptase, HIV protease (depending on formulation)

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 (Non-nucleoside reverse transcriptase inhibitor (NNRTI) class)

1. ViiV Healthcare · 4 drugs in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 3 drugs in this class
3. Merck Sharp & Dohme LLC · 2 drugs in this class
4. French National Agency for Research on AIDS and Viral Hepatitis · 1 drug in this class
5. Germans Trias i Pujol Hospital · 1 drug in this class
6. International Partnership for Microbicides, Inc. · 1 drug in this class
7. Janssen Infectious Diseases BVBA · 1 drug in this class
8. Janssen-Cilag S.p.A. · 1 drug in this class
9. Johns Hopkins Bloomberg School of Public Health · 1 drug in this class
10. Tibotec Pharmaceuticals, Ireland · 1 drug in this class