According to his data, the new medications were distributed among large pharmaceutical companies and small startups.
More than half of all approved drugs (55 percent) are the first in their class, meaning they have a new mechanism of action or significant differences from existing treatments. Of these, 31 drugs (61 percent) are classified as orphan drugs, intended for the treatment of rare diseases.
Among the indications, oncology traditionally dominates: in 2025, the world received 16 new medications to combat malignant tumors, followed by hematology (7 drugs), as well as treatments for metabolic, infectious, and respiratory diseases.
Among the significant new products are lenacapavir and suzetridine.
Lenacapavir is intended for HIV prevention among individuals at high risk of infection. It is administered twice a year and provides nearly 100 percent protection. In clinical trials involving more than 5,000 women from Africa, none of them contracted HIV while taking this drug, whereas the infection rate in control groups was nearly 2 percent.
Suzetridine is a new class of non-opioid analgesic designed for the treatment of acute pain. In the context of the global opioid crisis, this non-addictive and side-effect-free medication is considered a significant breakthrough.
Additionally, in 2025, the first new antibiotic for the treatment of gonorrhea in the last three decades was approved. Although antimicrobial resistance is inevitable with improper use, the emergence of a new class of antibiotics is a positive development.
In oncology, there were several outstanding news items: among them, a new therapy for ovarian cancer and a treatment for one type of brain cancer — glioma.
The company Cidara also presented interesting data on flu prevention with a single injection: the new drug demonstrated 76 percent effectiveness in reducing the likelihood of illness.
“The drug, named CD388, is a complex construct made up of molecules from an old antiviral drug linked to a fragment of an antibody. This combination circulates in the blood for a long time, allowing one injection to provide protection throughout the flu season against type A and B viruses. However, it is worth noting that it does not form immunity and is not formally considered a vaccine,” the article emphasizes.
Additionally, it is reported that Duchenne muscular dystrophy has long remained a challenging disease to treat. It is caused by mutations in one of the largest human genes — dystrophin, leading to gradual muscle weakening. Several RNA drugs and gene therapies already exist on the market, but debates about their effectiveness continue amid high prices.
“Capricor took an unconventional approach: instead of correcting the gene, it used donor heart muscle cells that release signaling molecules and help reduce inflammation. These specially prepared cells (cardiospheres) release exosomes to reduce inflammation and fibrosis in the muscles, as well as promote tissue regeneration. In the third phase of the study, the slowing of functional decline in patients was about 50 percent, and cardiac indicators declined nearly 10 times slower than in the placebo group. Although this does not represent a complete cure, the therapy significantly slows disease progression,” the author notes.
Furthermore, a new drug that targets the causes of narcolepsy has emerged.
“This disease affects 20-40 people per 100,000 population, and although it is relatively rare, it is quite unpleasant. Narcolepsy disrupts sleep-wake cycles, which can lead to sudden daytime sleepiness, negatively impacting quality of life and work performance. The disease can also be accompanied by cataplexy, sleep paralysis, and vivid hallucinations (although the name may be misleading, it is not related to drug addiction),” the article clarifies.
According to the author, at present, the treatment of narcolepsy is limited to symptomatic medications that reduce sleepiness and loss of muscle tone. The drug oveporexton from Takeda has become the first agent to demonstrate significant success in the third phase of studies, substantially reducing sleepiness as well as the number of sleep attacks and cataplexy episodes.
