According to the information provided by Yasny, the approved drugs were distributed among large pharmaceutical companies and small firms. More than half of them (55%) are new entries in their class, meaning they possess a unique mechanism of action or significant differences from already known medications. In particular, 31 of them (61%) are intended for the treatment of rare diseases.
The most sought-after indications remain oncological diseases, for which 16 new drugs were developed. Following this are drugs for the treatment of hematological, metabolic, infectious, and respiratory diseases.
Among the most significant newcomers are the drugs lenacapavir and suzetridine.
Lenacapavir is developed for the prevention of HIV in people at high risk of infection. It is administered only twice a year and provides nearly 100% protection. In clinical trials involving over 5,000 women from Africa, no cases of infection were registered among those taking lenacapavir, while in the control groups, the infection rate reached almost 2%.
Suzetridine is a new non-opioid analgesic designed for the treatment of acute pain syndrome. In the context of the global opioid dependence crisis, this discovery represents a significant breakthrough, as it does not cause addiction or other negative effects associated with opioids.
Another important approval in 2025 is the first new antibiotic for the treatment of gonorrhea in the last three decades. Despite the risk of resistance with improper use, the emergence of this new class of drug is considered a significant step forward.
In the field of oncology, there is also interesting news: a new therapy for ovarian cancer has been developed, as well as a drug against one type of glioma — a brain tumor.
Additionally, the company Cidara presented promising data on flu prevention with a single injection. The efficacy of the new drug was 76%, significantly reducing the risk of illness.
“The new drug CD388 consists of several molecules of an old antiviral agent linked to a fragment of an antibody. This allows it to remain in the bloodstream for a long time, providing protection throughout the flu season — against both type A and type B viruses. Notably, it does not form an immune response, so it is not classified as a vaccine,” the article notes.
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It is also mentioned that Duchenne muscular dystrophy remains one of the most challenging diseases to treat. This condition is caused by mutations in the dystrophin gene, leading to gradual muscle weakening. To date, various RNA drugs and gene therapy methods exist; however, the effectiveness of many of them remains questionable due to high costs.
“The company Capricor took an unconventional approach: instead of correcting the gene, they used donor heart muscle cells that secrete signaling molecules and reduce inflammation. These cells, called cardiospheres, release exosomes that reduce inflammation and fibrosis in both heart and skeletal muscles. Phase three studies showed that the deterioration of patients' conditions slowed down by almost 50%, and the decline in cardiac indicators occurred ten times more slowly than in the placebo group. Although there was no complete cure, the therapy significantly slowed the progression of the disease,” the author reports.
Moreover, a new drug has emerged that targets the causes of narcolepsy.
“This disease affects 20-40 people per 100,000 population, is relatively rare, but very severe. In narcolepsy, the balance of sleep and wakefulness is disrupted, which can lead to sudden, irresistible sleepiness during the day, severely negatively impacting quality of life and work performance. The disease is often accompanied by cataplexy, sleep paralysis, and vivid hallucinations, which are not related to drug addiction, despite the misleading name,” the article clarifies.
The author claims that existing treatments for narcolepsy are mainly symptomatic and aimed at reducing sleepiness and loss of muscle tone. However, the drug oveporexton from Takeda has become the first agent to show impressive results in phase three trials, significantly reducing levels of sleepiness and the number of episodes of falling asleep and cataplexy compared to placebo.
