Human Immunodeficiency Virus Infection
Infectious Disease 2 original drugsPhase 3 Readouts Pro
7 active Phase 3 trials with confidence-graded completion dates.
Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.
Treatments by Mechanism
Top 11 mechanisms across 42 industry trials with a known mechanism of action.
MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.
Clinical Pipeline by Phase
398 industry-sponsored trials across 69 sponsors
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Janssen Scientific Affairs, LLC | D/C/F/TAF FDC | — | COMPLETED | 2023-08-07 | NCT04442737 |
| Napo Pharmaceuticals, Inc. | Crofelemer delayed-release tablets 125mg | — | COMPLETED | 2021-08-31 | NCT04192487 |
| Merck | Raltegravir | — | COMPLETED | 2018-10-23 | NCT03667547 |
| ViiV Healthcare | Dolutegravir 50 mg | — | COMPLETED | 2018-10-01 | NCT03314064 |
| ViiV Healthcare | Lamivudine | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2016-03-01 | NCT02634073 |
| Gilead | STB | — | COMPLETED | 2016-01-20 | NCT02246998 |
| Janssen R&D Ireland | Etravirine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2013-11 | NCT01422330 |
| ViiV Healthcare | HIV therapy | — | COMPLETED | 2012-10 | NCT01275625 |
| Johnson & Johnson | TMC114/ritonavir | — | COMPLETED | 2012-06 | NCT01702090 |
| ViiV Healthcare | Reyataz + Norvir + Truvada | — | COMPLETED | 2012-06 | NCT01102972 |
| Bristol-Myers Squibb | Atazanavir | — | COMPLETED | 2011-06 | NCT01232127 |
| Gilead | emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) | — | COMPLETED | 2011-03 | NCT00724711 |
| Gilead | Truvada + Kaletra | — | COMPLETED | 2009-09 | NCT00772902 |
| Tibotec, Inc | ritonavir | Cytochrome P450 3A Inhibitor [EPC] | COMPLETED | 2009-08 | NCT00757783 |
| ViiV Healthcare | Maraviroc | CCR5 Co-receptor Antagonist [EPC] | COMPLETED | 2008-11 | NCT00717067 |
| Theratechnologies | Tesamorelin | — | TERMINATED | 2018-05 | NCT01591902 |
| ViiV Healthcare | maraviroc | CCR5 Co-receptor Antagonist [EPC] | WITHDRAWN | 2010-02 | NCT00782301 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Merck | MK-8527 | — | RECRUITING | 2027-07-22 | NCT07044297 |
| Merck | MK-8527 | — | RECRUITING | 2027-10-18 | NCT07071623 |
| Merck | ISL | — | RECRUITING | 2029-03-21 | NCT07266831 |
| Merck | MK-8591A | — | ACTIVE NOT RECRUITING | 2029-05-29 | NCT04776252 |
| ViiV Healthcare | Dolutegravir | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | ACTIVE NOT RECRUITING | 2026-03-24 | NCT05979311 |
| Merck | DOR/ISL | — | ACTIVE NOT RECRUITING | 2025-10-16 | NCT05766501 |
| Merck | DOR/ISL | — | ACTIVE NOT RECRUITING | 2025-10-13 | NCT05705349 |
| Gilead | B/F/TAF (Adult Strength) | — | ACTIVE NOT RECRUITING | 2025-03-24 | NCT02881320 |
| Merck | DOR/ISL | — | ACTIVE NOT RECRUITING | 2024-10-25 | NCT05630755 |
| Merck | ART | — | ACTIVE NOT RECRUITING | 2024-10-10 | NCT05631093 |
| Gilead | Oral Lenacapavir (LEN) | — | ACTIVE NOT RECRUITING | 2024-08-21 | NCT04925752 |
| Gilead | Oral Lenacapavir (LEN) | — | ACTIVE NOT RECRUITING | 2024-05-27 | NCT04994509 |
| Gilead | F/TAF | — | ACTIVE NOT RECRUITING | 2019-01-31 | NCT02842086 |
| ViiV Healthcare | Cabotegravir (CAB) tablet | — | ACTIVE NOT RECRUITING | 2018-05-29 | NCT02951052 |
| United BioPharma | UB-421 | — | NOT YET RECRUITING | 2026-06-30 | NCT04406727 |
| ViiV Healthcare | DTG/3TC | — | COMPLETED | 2026-01-23 | NCT05911360 |
| ViiV Healthcare | Cabotegravir - Injectable Suspension (CAB LA) | — | COMPLETED | 2023-09-14 | NCT05896748 |
| Merck | ISL | — | COMPLETED | 2022-11-21 | NCT04233216 |
| Merck | DOR/ISL | — | COMPLETED | 2022-11-17 | NCT04233879 |
| ViiV Healthcare | Cabotegravir Injectable Suspension | — | COMPLETED | 2022-08-23 | NCT05896761 |
| Merck | DOR/ISL | — | COMPLETED | 2021-09-08 | NCT04223778 |
| Merck | DOR/ISL | — | COMPLETED | 2021-08-26 | NCT04223791 |
| Johnson & Johnson | Darunavir | Protease Inhibitor [EPC] | COMPLETED | 2021-07-29 | NCT01281813 |
| Johnson & Johnson | Etravirine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2020-11-25 | NCT00980538 |
| CytoDyn, Inc. | PRO 140 (350 mg) | — | COMPLETED | 2020-09-16 | NCT02859961 |
| Janssen R&D Ireland | Rilpivirine | — | COMPLETED | 2020-02 | NCT01266902 |
| Gilead | F/TAF | — | COMPLETED | 2019-11-04 | NCT02285114 |
| Gilead | B/F/TAF | — | COMPLETED | 2019-08-12 | NCT03631732 |
| Sanofi | Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine | — | COMPLETED | 2019-02-22 | NCT02817451 |
| Janssen Scientific Affairs, LLC | DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC | — | COMPLETED | 2019-01-03 | NCT03227861 |
| Gilead | B/F/TAF | — | COMPLETED | 2018-11-20 | NCT03405935 |
| TaiMed Biologics Inc. | ibalizumab | — | COMPLETED | 2018-11 | NCT02707861 |
| ViiV Healthcare | DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets | — | COMPLETED | 2018-10-22 | NCT02075593 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2018-10-11 | NCT02616029 |
| International Partnership for Microbicides, Inc. | — | — | COMPLETED | 2018-10-10 | NCT02858037 |
| ViiV Healthcare | Dolutegravir (DTG) | — | COMPLETED | 2018-04-04 | NCT02831764 |
| ViiV Healthcare | Dolutegravir (DTG) | — | COMPLETED | 2018-03-29 | NCT02831673 |
| Merck | Doravirine, Tenofovir, Lamivudine | — | COMPLETED | 2018-02-22 | NCT02397096 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2018-02-21 | NCT02616783 |
| CytoDyn, Inc. | PRO 140 | — | COMPLETED | 2018-02 | NCT02483078 |
| Gilead | F/TAF | — | COMPLETED | 2017-12-11 | NCT02469246 |
| ViiV Healthcare | DTG 50 mg | — | COMPLETED | 2017-11-02 | NCT02178592 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2017-10-09 | NCT02652624 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2017-09-29 | NCT02600819 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2017-09-14 | NCT02707601 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2017-06-14 | NCT02605954 |
| Gilead | RTV | — | COMPLETED | 2017-05-15 | NCT02603107 |
| Gilead | DTG | — | COMPLETED | 2017-05-12 | NCT02607956 |
| Gilead | ABC/DTG/3TC | — | COMPLETED | 2017-05-09 | NCT02607930 |
| Gilead | ABC/DTG/3TC | — | COMPLETED | 2017-05-09 | NCT02603120 |
| Merck | Doravirine, Tenofovir, Lamivudine | — | COMPLETED | 2017-03-20 | NCT02403674 |
| AbbVie | ABT-493 coformulated with ABT-530 | — | COMPLETED | 2017-03-15 | NCT02738138 |
| Janssen R&D Ireland | D/C/F/TAF | — | COMPLETED | 2017-02 | NCT02269917 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2016-11-10 | NCT02276612 |
| TaiMed Biologics Inc. | ibalizumab | — | COMPLETED | 2016-10 | NCT02475629 |
| Merck | Doravirine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2016-09-29 | NCT02275780 |
| Janssen Scientific Affairs, LLC | Darunavir | Protease Inhibitor [EPC] | COMPLETED | 2016-08-11 | NCT00855335 |
| AbbVie | ABT-450/r/ABT-267 | — | COMPLETED | 2016-07-21 | NCT01939197 |
| Gilead | FTC/RPV/TAF | — | COMPLETED | 2016-06-29 | NCT02345226 |
| Gilead | FTC/RPV/TAF | — | COMPLETED | 2016-06-22 | NCT02345252 |
| Merck | Reformulated Raltegravir | — | COMPLETED | 2015-12-21 | NCT02131233 |
| Janssen-Cilag International NV | Rilpivirine | — | COMPLETED | 2015-10-22 | NCT01709084 |
| Institut Pasteur | cotrimoxazole daily prophylaxis | — | COMPLETED | 2015-10 | NCT01746199 |
| ViiV Healthcare | Dolutegravir/abacavir/lamivudine FDC | — | COMPLETED | 2015-09-22 | NCT01910402 |
| Biocad | Algeron | — | COMPLETED | 2015-08-26 | NCT02103439 |
| Gilead | FTC/TDF | — | COMPLETED | 2015-08-12 | NCT02121795 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2015-07-21 | NCT01968551 |
| Gilead | TAF | — | COMPLETED | 2015-05-21 | NCT01967940 |
| ViiV Healthcare | ABC/DTG/3TC FDC | — | COMPLETED | 2015-04 | NCT02105987 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2015-03-16 | NCT01815736 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2015-01-23 | NCT02071082 |
| Gilead | LDV/SOF | — | COMPLETED | 2014-11 | NCT02073656 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2014-09-19 | NCT01797445 |
| Bristol-Myers Squibb | Atazanavir Sulphate | — | COMPLETED | 2014-09-10 | NCT01335698 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2014-08-26 | NCT01780506 |
| Gilead | E/C/F/TAF | — | COMPLETED | 2014-07-31 | NCT01818596 |
| Janssen-Cilag International NV | Darunavir | Protease Inhibitor [EPC] | COMPLETED | 2014-06-11 | NCT01448707 |
| Gilead | Sofosbuvir | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC] | COMPLETED | 2014-04 | NCT01783678 |
| Gilead | SOF | — | COMPLETED | 2013-11 | NCT01667731 |
| Janssen-Cilag G.m.b.H | Darunavir/Ritonavir (DRV/r) | — | COMPLETED | 2013-08-01 | NCT01516970 |
| ViiV Healthcare | dolutegravir 50 mg OAD | — | COMPLETED | 2013-04-22 | NCT01449929 |
| ViiV Healthcare | GSK1349572 | — | COMPLETED | 2013-02-04 | NCT01231516 |
| ViiV Healthcare | Dolutegravir | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2012-10 | NCT01499199 |
| Gilead | FTC/RPV/TDF | — | COMPLETED | 2012-09 | NCT01309243 |
| ViiV Healthcare | Dolutegravir | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2012-05-14 | NCT01263015 |
| ViiV Healthcare | dolutegravir | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2012-05 | NCT01328041 |
| ViiV Healthcare | GSK1349572 (dolutegravir) | — | COMPLETED | 2012-02-06 | NCT01227824 |
| Gilead | FTC/RPV/TDF | — | COMPLETED | 2012-01 | NCT01252940 |
| Gilead | COBI | — | COMPLETED | 2011-11 | NCT01108510 |
| Gilead | Stribild | Cytochrome P450 3A Inhibitor [EPC] | COMPLETED | 2011-09 | NCT01106586 |
| Chiltern Pesquisa Clinica Ltda | Focetria® | — | COMPLETED | 2011-09 | NCT01032408 |
| Gilead | Stribild | Cytochrome P450 3A Inhibitor [EPC] | COMPLETED | 2011-08 | NCT01095796 |
| Merck | Comparator: raltegravir | — | COMPLETED | 2011-02 | NCT00764946 |
| Gilead | Elvitegravir | — | COMPLETED | 2010-12 | NCT00708162 |
| Tibotec Pharmaceuticals, Ireland | TMC278 | — | COMPLETED | 2010-02 | NCT00540449 |
| Tibotec Pharmaceuticals, Ireland | TMC278 | — | COMPLETED | 2010-01 | NCT00543725 |
| Abbott | lopinavir/ritonavir (LPV/r) | — | COMPLETED | 2009-11 | NCT00711009 |
| Abbott Diagnostics Division | — | — | COMPLETED | 2009-10 | NCT00933933 |
| Merck | Islatravir | — | TERMINATED | 2023-07-18 | NCT04644029 |
| CytoDyn, Inc. | PRO 140 | — | TERMINATED | 2022-06 | NCT02990858 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Shanxi Kangbao Biological Product Co., Ltd. | LP-98 20 mg | — | RECRUITING | 2026-07-10 | NCT07433387 |
| Henan Genuine Biotech Co., Ltd. | CL-197 capsules | — | RECRUITING | 2026-12 | NCT07308782 |
| Merck | Doravirine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | RECRUITING | 2028-11-12 | NCT04375800 |
| Jiangsu Aidea Pharmaceutical Group Co., Ltd. | ACC017+FTC/TAF | — | RECRUITING | 2025-08 | NCT06719310 |
| Code Pharma | Dispensing Codivir® | — | RECRUITING | 2024-12 | NCT06676410 |
| Gilead | Lenacapavir Tablet | — | ACTIVE NOT RECRUITING | 2026-07 | NCT06101329 |
| Johnson & Johnson | Rilpivirine | — | ACTIVE NOT RECRUITING | 2026-08-18 | NCT02494986 |
| Merck | ISL | — | ACTIVE NOT RECRUITING | 2027-08-10 | NCT06891066 |
| Gilead | Lenacapavir Injection | — | ACTIVE NOT RECRUITING | 2028-01 | NCT06101342 |
| Gilead | Lenacapavir Injection | — | ACTIVE NOT RECRUITING | 2026-05 | NCT06513312 |
| Gilead | Teropavimab | — | ACTIVE NOT RECRUITING | 2024-07-02 | NCT05729568 |
| Gilead | ISL | — | ACTIVE NOT RECRUITING | 2023-12-19 | NCT05052996 |
| MGB Pharma | The monoterpenoid zinc tetra-ascorbo-camphorate ("C14") | — | NOT YET RECRUITING | 2025-03-15 | NCT06672653 |
| Merck | Islatravir | — | COMPLETED | 2025-01-30 | NCT04564547 |
| Shanxi Kangbao Biological Product Co., Ltd. | Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98. | — | COMPLETED | 2025-01-10 | NCT06560489 |
| Merck | MK-8527 | — | COMPLETED | 2024-12-12 | NCT06045507 |
| Shanxi Kangbao Biological Product Co., Ltd. | Lipovirtide 10mg | — | COMPLETED | 2024-11-29 | NCT06061536 |
| Johnson & Johnson | Rilpivirine | — | COMPLETED | 2023-02-17 | NCT04012931 |
| United BioPharma | UB-421 | — | COMPLETED | 2023-02-01 | NCT05056974 |
| Sanofi | CYD Dengue Vaccine | — | COMPLETED | 2023-01-19 | NCT02741128 |
| Johnson & Johnson | Rilpivirine | — | COMPLETED | 2022-08 | NCT00799864 |
| Merck | Islatravir | — | COMPLETED | 2022-03-18 | NCT04003103 |
| Merck | DOR/ISL | — | COMPLETED | 2021-12-21 | NCT04295772 |
| Merck | Islatravir | — | COMPLETED | 2021-03-08 | NCT03272347 |
| United BioPharma | UB-421(25 mg/kg) Q2W | — | COMPLETED | 2020-10-15 | NCT03743376 |
| Merck | Doravirine/lamivudine/tenofovir disoproxil fumarate | — | COMPLETED | 2018-11-28 | NCT02629822 |
| Janssen Vaccines & Prevention B.V. | Ad26.Mos.HIV | — | COMPLETED | 2018-09 | NCT02919306 |
| Merck | Doravirine, Tenofovir, Lamivudine - Blinded | — | COMPLETED | 2018-08-14 | NCT02652260 |
| Environment and Health Group, Inc. | — | — | COMPLETED | 2018-06-30 | NCT03810170 |
| Sangamo Therapeutics | Cyclophosphamide | DNA | COMPLETED | 2018-06 | NCT02225665 |
| GSK | GSK2838232 | — | COMPLETED | 2018-04-23 | NCT03045861 |
| Johnson & Johnson | Darunavir | Protease Inhibitor [EPC] | COMPLETED | 2017-11-23 | NCT01138605 |
| Calimmune, Inc. | Busulfan | Alkylating Drug [EPC] | COMPLETED | 2017-09 | NCT01734850 |
| Abivax S.A. | ABX464 | — | COMPLETED | 2017-08-30 | NCT02735863 |
| Sangamo Therapeutics | — | — | COMPLETED | 2017-07-07 | NCT01543152 |
| International Partnership for Microbicides, Inc. | — | — | COMPLETED | 2016-07-05 | NCT02028338 |
| United BioPharma | UB-421 | — | COMPLETED | 2016-07 | NCT02369146 |
| Abivax S.A. | ABX464 | — | COMPLETED | 2015-12 | NCT02452242 |
| Gilead | BIC | — | COMPLETED | 2015-11-30 | NCT02397694 |
| ViiV Healthcare | CAB Oral Tablets | — | COMPLETED | 2015-08-13 | NCT02120352 |
| ViiV Healthcare | 744 Tablet | — | COMPLETED | 2015-05-15 | NCT02076178 |
| International Partnership for Microbicides, Inc. | Dapivirine Vaginal Ring | — | COMPLETED | 2015-04 | NCT02010593 |
| CytoDyn, Inc. | PRO 140 | — | COMPLETED | 2015-02-02 | NCT02175680 |
| Sangamo Therapeutics | SB-728-T | — | COMPLETED | 2014-12 | NCT01252641 |
| ViiV Healthcare | BMS-955176 | — | COMPLETED | 2014-11-29 | NCT01803074 |
| Gilead | Simtuzumab | — | COMPLETED | 2014-10-17 | NCT01707472 |
| Theravectys S.A. | THV01-1 | — | COMPLETED | 2014-08 | NCT02054286 |
| Bionor Immuno AS | Lenalidomide | Thalidomide Analog [EPC] | COMPLETED | 2014-08 | NCT01704781 |
| Argos Therapeutics | AGS-004 | — | COMPLETED | 2014-08 | NCT01069809 |
| United Biomedical | Antibody UB-421 | — | COMPLETED | 2014-03 | NCT01668043 |
| Bionor Immuno AS | Vacc-4x | — | COMPLETED | 2014-01 | NCT01712256 |
| Merck | Raltegravir Film-coated Tablet | — | COMPLETED | 2013-12-11 | NCT01717287 |
| Viriom | VM-1500/Placebo | — | COMPLETED | 2013-12 | NCT02485509 |
| Bionor Immuno AS | Vacc-C5/GM-CSF | — | COMPLETED | 2013-11 | NCT01627678 |
| ViiV Healthcare | GSK1265744 10 mg | — | COMPLETED | 2013-10-10 | NCT01641809 |
| Gilead | SOF | — | COMPLETED | 2013-08 | NCT01565889 |
| ViiV Healthcare | BMS-663068 400 mg | — | COMPLETED | 2013-02-18 | NCT01384734 |
| InnaVirVax | VAC-3S | — | COMPLETED | 2013-02 | NCT01549119 |
| Tobira Therapeutics, Inc. | Cenicriviroc 100 mg | — | COMPLETED | 2012-12 | NCT01338883 |
| Tibotec, Inc | Etravirine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2012-10 | NCT01199939 |
| Genetic Immunity | DermaVir | — | COMPLETED | 2011-12 | NCT00711230 |
| Pfizer | UK-453, 061 | — | COMPLETED | 2011-10 | NCT00824421 |
| Gilead | FTC/RPV/TDF | — | COMPLETED | 2011-07 | NCT01286740 |
| Tibotec Pharmaceuticals, Ireland | Etravirine (TMC125) | — | COMPLETED | 2011-05 | NCT00665847 |
| TaiMed Biologics Inc. | Ibalizumab | — | COMPLETED | 2011-04 | NCT00784147 |
| Janssen-Cilag S.p.A. | Darunavir(DRV) | — | COMPLETED | 2011-04 | NCT01391013 |
| International Partnership for Microbicides, Inc. | dapivirine 4789 | — | COMPLETED | 2011-01-08 | NCT00799058 |
| ViiV Healthcare | GSK1349572 (Cohort I) | — | COMPLETED | 2010-11 | NCT00950859 |
| Tibotec Pharmaceuticals, Ireland | darunavir | Protease Inhibitor [EPC] | COMPLETED | 2010-09 | NCT00915655 |
| Tibotec Pharmaceuticals, Ireland | Darunavir | Protease Inhibitor [EPC] | COMPLETED | 2010-08 | NCT00919854 |
| ViiV Healthcare | maraviroc | CCR5 Co-receptor Antagonist [EPC] | COMPLETED | 2010-07 | NCT00827112 |
| ViiV Healthcare | GSK1349572 | — | COMPLETED | 2010-02-26 | NCT00951015 |
| Janssen-Cilag International NV | etravirine (ETR, TMC125) | — | COMPLETED | 2010-02 | NCT00903682 |
| Gilead | COBI | — | COMPLETED | 2009-12 | NCT00892437 |
| ViiV Healthcare | GSK2248761 | — | COMPLETED | 2009-11-28 | NCT00945282 |
| Gilead | Stribild | Cytochrome P450 3A Inhibitor [EPC] | COMPLETED | 2009-11 | NCT00869557 |
| Tobira Therapeutics, Inc. | TBR-652 | — | COMPLETED | 2009-11 | NCT01092104 |
| ViiV Healthcare | GSK1265744 30mg | — | COMPLETED | 2009-08-13 | NCT00920426 |
| Tibotec Pharmaceuticals, Ireland | TMC310911 75 mg twice daily | — | COMPLETED | 2009-08 | NCT00838162 |
| Myrexis Inc. | Bevirimat | — | COMPLETED | 2009-01 | NCT01097070 |
| ViiV Healthcare | GSK1349572 | — | COMPLETED | 2008-08 | NCT00708110 |
| Tibotec, Inc | TMC125; darunavir; ritonavir | — | COMPLETED | 2008-05 | NCT00534352 |
| CytoDyn, Inc. | PRO 140 350mg weekly subcutaneous (SC) injection. | — | TERMINATED | 2022-06 | NCT02355184 |
| Janssen Vaccines & Prevention B.V. | Ad26.Mos4.HIV | — | TERMINATED | 2022-02-02 | NCT03060629 |
| ViiV Healthcare | BMS-955176 | — | TERMINATED | 2016-05-26 | NCT02415595 |
| Pfizer | No drug will be administered | — | TERMINATED | 2013-07 | NCT00824369 |
| Cytheris SA | Interleukin-7 | — | TERMINATED | 2013-06 | NCT01190111 |
| Cytheris SA | CYT107 | — | TERMINATED | 2013-06 | NCT01241643 |
| Pfizer | lersivirine | — | TERMINATED | 2013-04 | NCT01254656 |
| Bristol-Myers Squibb | BMS-986001 | — | TERMINATED | 2013-03 | NCT01489046 |
| RFS Pharma, LLC | amdoxovir 300 mg bid | — | TERMINATED | 2013-02 | NCT01737359 |
| Pfizer | UK-453,061 Dose 1 | — | TERMINATED | 2012-10-18 | NCT00823979 |
| ViiV Healthcare | GSK2248761 100 mg once daily | — | TERMINATED | 2011-07-19 | NCT01199731 |
| ViiV Healthcare | GSK2248761 100 mg once daily | — | TERMINATED | 2011-07-04 | NCT01231555 |
| Bristol-Myers Squibb | Atazanavir | — | TERMINATED | 2010-01 | NCT00768989 |
| Merck | Islatravir | — | WITHDRAWN | 2025-10-02 | NCT05115838 |
| Merck | Islatravir | — | WITHDRAWN | 2024-03-25 | NCT05130086 |
| United BioPharma | UB-421 | — | WITHDRAWN | 2020-12 | NCT04041362 |
| CytoDyn, Inc. | PRO 140 | — | WITHDRAWN | 2017-01 | NCT01272258 |
| RFS Pharma, LLC | amdoxovir 300 mg bid | — | WITHDRAWN | 2014-08 | NCT01738555 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Merck | MK-4646 | — | RECRUITING | 2026-07-08 | NCT07042945 |
| Immuno Cure Holding (HK) Limited | ICVAX (TERESA-EPT I device) | — | RECRUITING | 2027-03-31 | NCT07530198 |
| Jecho Biopharmaceuticals Co., Ltd. | JL18008 | — | NOT YET RECRUITING | 2029-12-20 | NCT07443228 |
| Immuno Cure Holding (HK) Limited | ICVAX | — | COMPLETED | 2024-09-30 | NCT06253533 |
| MacroGenics | MGD020 | — | COMPLETED | 2024-05-29 | NCT05261191 |
| Shanxi Kangbao Biological Product Co., Ltd. | LP-98 injection | — | COMPLETED | 2024-04-12 | NCT05933824 |
| Merck | MK-8527 | — | COMPLETED | 2024-01-31 | NCT05494736 |
| Henan Genuine Biotech Co., Ltd. | 1 mg CL-197 capsules | — | COMPLETED | 2024-01-20 | NCT05944848 |
| Merck | MK-8527 | — | COMPLETED | 2023-10-11 | NCT06783192 |
| AbbVie | ABBV-382 | — | COMPLETED | 2023-08-14 | NCT04554966 |
| AbbVie | ABBV-181 | — | COMPLETED | 2023-02-27 | NCT04223804 |
| AbbVie | Budigalimab | — | COMPLETED | 2022-10-11 | NCT04799353 |
| Johnson & Johnson | DRV/COBI FDC | — | COMPLETED | 2022-09-23 | NCT05197075 |
| American Gene Technologies International Inc. | AGT103-T | — | COMPLETED | 2022-08-15 | NCT04561258 |
| Gilead | Oral Lenacapavir | — | COMPLETED | 2022-06-09 | NCT04811040 |
| United BioPharma | UB-421 SC(dB4C7C22-6 mAb) | — | COMPLETED | 2022-05-25 | NCT04620304 |
| Jiangsu HengRui Medicine Co., Ltd. | SHR2150;Placebo | — | COMPLETED | 2021-11-10 | NCT04802811 |
| Janssen Vaccines & Prevention B.V. | Ad26.Mos4.HIV | — | COMPLETED | 2021-11-05 | NCT03307915 |
| Merck | Islatravir | — | COMPLETED | 2021-09-13 | NCT04515641 |
| Merck | Islatravir | — | COMPLETED | 2021-07-09 | NCT04568603 |
| Merck | Islatravir | — | COMPLETED | 2020-10-19 | NCT04303156 |
| Aelix Therapeutics | DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM) | — | COMPLETED | 2020-07-01 | NCT03204617 |
| Merck | MK-8558 | — | COMPLETED | 2020-05-29 | NCT03859739 |
| Janssen Pharmaceutica N.V., Belgium | D/C/F/TAF FDC placebo | — | COMPLETED | 2020-03-06 | NCT04006704 |
| Gilead | Vesatolimod | — | COMPLETED | 2020-02-13 | NCT03060447 |
| Gilead | Lenacapavir | — | COMPLETED | 2019-11-14 | NCT03739866 |
| Merck | MK-8527 | — | COMPLETED | 2019-09-26 | NCT03615183 |
| ViiV Healthcare | Cabotegravir tablet 30 mg once daily for 28 days. | — | COMPLETED | 2019-07-25 | NCT02478463 |
| Merck | MK-8583 | — | COMPLETED | 2019-03-11 | NCT03552536 |
| Gilead | Vesatolimod | — | COMPLETED | 2019-02-14 | NCT02858401 |
| Antiva Biosciences | ABI-1968 | — | COMPLETED | 2019-02-04 | NCT03202992 |
| Merck | MK-4250 | — | COMPLETED | 2018-11-02 | NCT03351699 |
| ViiV Healthcare | GSK3640254 | — | COMPLETED | 2018-09-09 | NCT03231943 |
| KBio Inc | MB66 | — | COMPLETED | 2018-07 | NCT02579083 |
| Merck | MK-8504 | — | COMPLETED | 2018-05-21 | NCT03188523 |
| International Partnership for Microbicides, Inc. | Dapivirine | — | COMPLETED | 2018-03-03 | NCT02808949 |
| GSK | — | — | COMPLETED | 2018-01-30 | NCT03368053 |
| GSK | GSK2838232 100 mg tablet | — | COMPLETED | 2017-11-10 | NCT03234036 |
| ViiV Healthcare | Cabotegravir | — | COMPLETED | 2017-09-06 | NCT03149848 |
| ViiV Healthcare | Dolutegravir | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2017-08-18 | NCT03078556 |
| Johnson & Johnson | DRV/COBI FDC placebo tablet | — | COMPLETED | 2017-05-25 | NCT02993237 |
| Merck | 1 mg islatravir | — | COMPLETED | 2017-05-11 | NCT02217904 |
| GSK | GSK2838232 PIB | — | COMPLETED | 2016-12 | NCT02795754 |
| ViiV Healthcare | GSK1265744 30 mg | — | COMPLETED | 2016-11-01 | NCT02354937 |
| ViiV Healthcare | DTG/ABC/3TC FDC DISPERSIBLE TABLET | — | COMPLETED | 2016-11-01 | NCT02893488 |
| ViiV Healthcare | DTG | — | COMPLETED | 2016-10-24 | NCT02741557 |
| International Partnership for Microbicides, Inc. | DS003 vaginal tablet | — | COMPLETED | 2016-08-26 | NCT02877979 |
| ViiV Healthcare | BMS-955176 | — | COMPLETED | 2016-08-15 | NCT02273947 |
| ViiV Healthcare | BMS-663068 (1 tablet at 600 mg) | — | COMPLETED | 2016-08-12 | NCT02859259 |
| ViiV Healthcare | Cabotegravir 30 mg | — | COMPLETED | 2016-08 | NCT02799264 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2016-06-29 | NCT02666001 |
| Merck | Methadone | — | COMPLETED | 2016-06-13 | NCT02715700 |
| ViiV Healthcare | Dolutegravir 50 mg tablet | — | COMPLETED | 2016-06 | NCT02738931 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2016-05-05 | NCT02805556 |
| ViiV Healthcare | Dolutegravir | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2016-05 | NCT02715479 |
| Janssen Infectious Diseases BVBA | Rilpivirine (RPV) | — | COMPLETED | 2016-04-26 | NCT02547870 |
| International Partnership for Microbicides, Inc. | Dapivirine Vaginal Ring-004 and no tampons | — | COMPLETED | 2016-04-16 | NCT02858024 |
| ApoPharma | Intravenous deferiprone | — | COMPLETED | 2016-03 | NCT02456558 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2016-02-22 | NCT02666053 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2016-01-11 | NCT02480881 |
| Merck | Treatment A: Doravirine 100 mg film coated tablet | — | COMPLETED | 2015-12-24 | NCT02549040 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2015-11-05 | NCT02508064 |
| ViiV Healthcare | ABC/DTG/3TC FDC tablet | — | COMPLETED | 2015-11 | NCT02539576 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2015-10-03 | NCT02467335 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2015-09-21 | NCT02480894 |
| ViiV Healthcare | DTG 50 mg | — | COMPLETED | 2015-09 | NCT02373930 |
| ViiV Healthcare | CAB | — | COMPLETED | 2015-09 | NCT02411435 |
| Merck | Raltegravir 1200 mg | — | COMPLETED | 2015-08-29 | NCT02473367 |
| Merck | Ulonivirine | — | COMPLETED | 2015-07-16 | NCT02174159 |
| Gilead | Bictegravir | — | COMPLETED | 2015-07-06 | NCT02400307 |
| Ratiopharm GmbH | Nevirapine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2015-07 | NCT02202005 |
| ViiV Healthcare | Cabotegravir 30 mg current formulation | — | COMPLETED | 2015-06 | NCT02345707 |
| Gilead | Bictegravir | — | COMPLETED | 2015-01-23 | NCT02275065 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2015-01-12 | NCT02277600 |
| ViiV Healthcare | Ethinyl Estadiol | — | COMPLETED | 2014-12 | NCT02159131 |
| Sangamo Therapeutics | — | — | COMPLETED | 2014-12 | NCT01044654 |
| ViiV Healthcare | Dolutegravir Pediatric Granules | — | COMPLETED | 2014-09 | NCT02185300 |
| ViiV Healthcare | BMS-955176 | — | COMPLETED | 2014-08-25 | NCT02157467 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2014-07-25 | NCT02164045 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2014-07-24 | NCT02138084 |
| ViiV Healthcare | BMS-955176 | — | COMPLETED | 2014-07-07 | NCT02095886 |
| ViiV Healthcare | GSK1265744 Reference formulation | — | COMPLETED | 2014-06 | NCT02059031 |
| ViiV Healthcare | GSK1265744 | — | COMPLETED | 2014-06 | NCT02027454 |
| Merck | Doravirine | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] | COMPLETED | 2014-05-12 | NCT02089659 |
| ViiV Healthcare | BMS-663068 | — | COMPLETED | 2014-05-01 | NCT02063360 |
| GeoVax, Inc. | JS7 plasmid DNA and MVA62B vaccine | — | COMPLETED | 2014-05 | NCT01378156 |
| ViiV Healthcare | DTG | — | COMPLETED | 2014-05 | NCT02082808 |
| ViiV Healthcare | Metformin 500 mg q12h | — | COMPLETED | 2014-05 | NCT02064374 |
| ViiV Healthcare | GSK1265744 30 mg oral | — | COMPLETED | 2014-04 | NCT01754116 |
| International Partnership for Microbicides, Inc. | — | — | COMPLETED | 2014-03 | NCT01755754 |
| ViiV Healthcare | DTG | — | COMPLETED | 2014-01 | NCT01967771 |
| GSK | GSK2838232 | — | COMPLETED | 2013-11-21 | NCT01802918 |
| ViiV Healthcare | GSK1265744 Oral | — | COMPLETED | 2013-11 | NCT01593046 |
| International Partnership for Microbicides, Inc. | — | — | COMPLETED | 2013-10 | NCT01755741 |
| International Partnership for Microbicides, Inc. | dapivirine | — | COMPLETED | 2013-10 | NCT01731574 |
| Bristol-Myers Squibb | Atazanavir | — | COMPLETED | 2013-06 | NCT01837719 |
| PX'Therapeutics | EN41-FPA2 HIV vaccine | — | COMPLETED | 2013-06 | NCT01509144 |
| ViiV Healthcare | Dolutegravir 50 mg | — | COMPLETED | 2013-03 | NCT01762995 |
| ViiV Healthcare | GSK1265744 injectable suspension | — | COMPLETED | 2012-12 | NCT01756131 |
| ViiV Healthcare | GSK1265744 Na Salt Tablets | — | COMPLETED | 2012-11 | NCT01648257 |
Novel Drugs by Company (New molecular entities)
Reformulations (8 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Drug Targets
Generic Drugs (3 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs