Clinical Trials
279
27 active
Approvals
53
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
Active, not recruiting
24
8.6%
Available
2
0.7%
Completed
212
76.0%
No Longer Available
3
1.1%
Not yet recruiting
3
1.1%
Recruiting
11
3.9%
Terminated
18
6.5%
Unknown
1
0.4%
Withdrawn
5
1.8%
- The global long-acting drugs market is forecast to grow from US$ 7.2 billion in 2026 to US$ 13.3 billion by 2033, representing a compound annual growth rate of 8.9%. - Rising prevalence of chronic diseases including cancer, diabetes, HIV, and CNS disorders is accelerating demand for sustained-release therapies that reduce dosing frequency and improve adherence. - Eli Lilly's oral GLP-1 receptor agonist orforglipron demonstrated superior A1C and body weight reduction versus oral semaglutide in Phase III trials, signaling a shift toward oral long-acting metabolic therapies. - Microsphere-based delivery systems dominate the technology segment, while North America leads the market with a 41.2% share and Asia Pacific emerges as the fastest-growing region.
- ViiV Healthcare's Dovato demonstrated significantly lower rates of steatotic liver disease compared to Gilead's Biktarvy in HIV patients after 96 weeks of treatment. - The Phase IV PASO DOBLE study showed 29% of Dovato patients developed steatotic liver disease versus 49% of Biktarvy patients, with the most pronounced difference in patients with clinically meaningful weight gain. - The findings highlight important metabolic health differences between two-drug and three-drug HIV regimens, providing new insights for treatment selection in virologically suppressed HIV patients.
- ViiV Healthcare presents first-in-human data for VH184, the first third-generation integrase inhibitor with potential for four-month or longer dosing intervals, marking a significant advancement in ultra long-acting HIV treatment. - The phase IIb EMBRACE study reports 12-month data on HIV suppression and safety with investigational lotivibart (N6LS) administered every four months in combination with monthly cabotegravir. - Clinical data from the VOLITION study shows Month 11 outcomes for treatment-naïve adults switching to long-acting cabotegravir + rilpivirine immediately after achieving viral suppression. - Real-world evidence from the OPERA cohort demonstrates three-year effectiveness data for cabotegravir long-acting for PrEP, including high effectiveness among Black women disproportionately impacted by HIV.
- Shionogi will invest $2.13 billion to increase its economic interest in ViiV Healthcare to 21.7% as Pfizer exits its 11.7% stake in the HIV specialist company. - The transaction simplifies ViiV Healthcare's shareholder structure while maintaining GSK's 78.3% majority ownership of the global HIV medicines developer. - ViiV Healthcare currently markets 15 prescription HIV medicines and is developing ultra long-acting therapies, competing in a market forecast to grow from $26.5 billion in 2023 to $32.1 billion by 2033. - The deal is expected to complete in the first quarter of 2026, subject to regulatory clearances, strengthening the partnership between GSK and Shionogi in HIV drug development.
- Adolescents with HIV who switched from daily oral medications to injectable cabotegravir and rilpivirine every eight weeks showed no major safety concerns and maintained viral suppression after 48 weeks. - The IMPAACT 2017/MOCHA study enrolled 144 participants across five countries and represents the largest multinational experience with all-injectable HIV treatment in adolescents. - All participants (100%) reported preferring the injectable regimen over daily oral medications, with 140 of 144 continuing treatment through the 48-week study period. - The findings support the FDA-approved treatment option for adolescents 12 years or older weighing 35 kilograms or more, offering freedom from daily medication adherence challenges.
- GSK has entered into an agreement with the U.S. Administration to lower prescription medicine costs for American patients, specifically targeting respiratory treatments for over 40 million Americans with asthma and COPD. - The company will offer savings of up to 66% on most of its inhaled respiratory portfolio through a direct purchasing platform and reduce prices for certain medicines in Medicaid. - As part of the President's Strategic Active Pharmaceutical Ingredients Reserve, GSK will secure a U.S. reserve of albuterol, the active ingredient used in inhalers for asthma and COPD symptom relief. - The agreement provides GSK and ViiV Healthcare with pricing framework clarity and excludes both companies from s232 tariffs for three years.
- ViiV Healthcare's PASO DOBLE trial shows Dovato (DTG/3TC) maintains viral suppression as effectively as Biktarvy (BIC/FTC/TAF) at 96 weeks in 553 virologically suppressed HIV-1 patients. - Patients taking Dovato experienced significantly less weight gain (0.84kg vs 2.35kg) and fewer drug-related adverse events (7.6% vs 13.4%) compared to Biktarvy over two years. - The phase IV randomized trial represents the largest head-to-head comparison between these HIV regimens, with Dovato showing zero virological failures versus three in the Biktarvy arm. - Results support the clinical benefit of two-drug versus three-drug HIV regimens for long-term treatment optimization in virologically suppressed patients.
- The National Institute for Health and Care Excellence (NICE) has recommended cabotegravir long-acting injection for HIV prevention in England and Wales, offering an alternative to daily oral PrEP for high-risk individuals who cannot take oral medications. - Clinical trials demonstrated superior efficacy with 69% and 90% lower HIV acquisition rates compared to daily oral tenofovir disoproxil fumarate/emtricitabine in men who have sex with men and cisgender women, respectively. - The bimonthly injection is expected to benefit up to 1,000 people annually in England, with rollout beginning approximately three months after final guidance publication later this year. - Real-world evidence from six studies shows more than 99% effectiveness of cabotegravir long-acting at preventing HIV, supporting the UK's ambitious goal of eliminating new HIV transmissions by 2030.
- Researchers at CRCHUM will launch the RESTART trial this fall to test whether fostemsavir can improve cardiovascular health in HIV patients by targeting the toxic viral protein gp120. - The study found that gp120 circulates in blood as a viral toxin in one-third of HIV patients, causing immune system self-destruction even when viral load is undetectable. - Fostemsavir uniquely deforms gp120 protein and reduces harmful antibodies, potentially restoring immune function beyond traditional viral suppression approaches. - The two-year trial will recruit 150 participants with detectable gp120 levels and measure coronary plaque progression as a cardiovascular health endpoint.
- CVS Health, the largest U.S. pharmacy benefit manager, will not add Gilead's new HIV prevention drug Yeztugo to its commercial plans, citing clinical, financial, and regulatory factors despite the drug's proven 99.9% effectiveness. - The decision reflects concerns over Yeztugo's $28,000 annual list price, with CVS stating it's inappropriate for manufacturers to manipulate guidelines with clinically similar products priced far higher than existing options. - AIDS activists call the decision a "grave disappointment" and missed opportunity, as Yeztugo could be transformative in ending the HIV epidemic that infects 1.3 million people annually. - Gilead remains confident in securing 75% U.S. insurer coverage by year-end and 90% by June 2026, with government programs and several state Medicaid plans already providing coverage.
