According to his data, the new drugs were evenly distributed between large pharmaceutical companies and small startups.
Among all approved drugs, more than half (55%) are the first in their class, meaning they have a new mechanism of action or significant differences from existing analogs. Of these, 31 (61%) are intended for the treatment of rare diseases.
In terms of indications in traditional medicine, oncology remains the leading area, with 16 new drugs introduced in 2025 to combat malignant tumors, followed by hematology (7 new agents) and diseases of metabolic, infectious, and respiratory nature.
Among the most significant innovations of 2025 are the drugs lenacapavir and suzetreidgin.
Lenacapavir is intended for the prevention of HIV among at-risk groups and is administered only twice a year, providing nearly 100% protection. In clinical trials involving more than 5,000 women from Africa, none of the participants receiving lenacapavir contracted HIV, while the infection rate in the control group reached almost 2%.
Suzetreidgin is a new non-opioid analgesic for the treatment of acute pain. In the context of the global opioid crisis, this drug, which does not cause dependence or other negative effects, has become a significant achievement.
Also, in 2025, the first new antibiotic for the treatment of gonorrhea in the last 30 years was approved. Although resistance may develop with improper use, the emergence of a new class of antibiotics is always seen as a positive event.
Important developments also occurred in oncology: a new therapy for the treatment of ovarian cancer was developed, and a drug for one type of brain cancer associated with glioma was approved.
Additional data from Cidara showed that a new drug for the prevention of influenza provides protection at a level of 76% — this is how much the risk of falling ill is reduced when using the new agent.
“The CD388 drug represents a unique construct consisting of several molecules of an old antiviral drug linked to antibodies. This allows it to remain in the body for a long time and provide protection throughout the flu season against viruses of types A and B. However, it does not form an immune response, and therefore cannot be considered a vaccine,” the article emphasizes.
It is also noted that Duchenne muscular dystrophy has long remained a challenging target for therapy. This disease is associated with mutations in the dystrophin gene, leading to gradual muscle weakening. Several RNA drugs and gene therapies are already on the market, but their effectiveness and high cost generate controversy.
“Capricor has chosen an alternative approach: instead of correcting the gene, it used donor heart muscle cells that release signaling molecules and reduce inflammation. These cells, called cardiospheres, release exosomes that help reduce inflammatory processes and fibrosis in the cardiovascular and skeletal muscles. In triple-phase studies, the slowing of functional decline in patients was about 50%, and cardiac indicators decreased almost 10 times slower than in the placebo group. Although this is not a cure, the therapy significantly slows the progression of the disease,” the author reports.
A drug targeting the cause of narcolepsy has also been introduced.
“This disease affects 20-40 people per 100,000 population, making it relatively rare but very unpleasant. Narcolepsy leads to disruptions in sleep and wakefulness, causing sudden bouts of drowsiness, which negatively impacts quality of life and work capacity. This condition is often accompanied by cataplexy, sleep paralysis, and vivid hallucinations,” the article specifies.
According to the author, treatment for narcolepsy currently relies on symptomatic agents that help control drowsiness and loss of tone. The drug oveporexton from Takeda has become the first agent to show outstanding results in phase three clinical trials, significantly reducing drowsiness, the number of episodes of falling asleep, and cataplexy compared to placebo.
