In a roundabout way: a new domestic drug for anesthesia has begun to be used
A domestic drug for anesthesia, Remifentanil, has entered clinical use in Russia — the first operation using it has taken place, and 150 more are scheduled by the end of 2025. This was reported to Izvestia by the manufacturer of medicines FSUE Moscow Endocrine Plant. The new anesthetic is used only for complex operations: it is administered intravenously in combination with artificial ventilation. Previously, innovative remifentanyl-based drugs were not used in Russia. About how import substitution is taking place in the field of anesthesiology and how the state is expanding the range of available drugs, see the Izvestia article.
The use of a new Russian anesthetic
The first operation using the domestic innovative anesthetic drug Remifentanil was performed in Russia, the press service of the Moscow Endocrine Plant told Izvestia. At the end of October 2025, the drug was used during laparoscopic resection (partial removal) of the kidney of a 60-year-old patient, which was performed by doctors of the Moscow Multidisciplinary Clinical Center "Kommunarka". The anesthetic was administered intravenously in combination with artificial lung ventilation.
This drug, which is new to anesthesiologists and intensive care specialists, is intended for use in a wide range of clinical situations, in particular, for extensive and minimally invasive operations that require stable maintenance of anesthesia.
Domestic remifentanil was registered in August 2024 — to date, production lines have produced more than 25 thousand vials of the drug. The drug can be used for adult patients under general anesthesia during long-term operations or with difficult-to-predict duration (pulmonary, neurosurgical, painful abdominal operations). In addition, the drug is indicated for adult patients at risk for renal, hepatic, or heart failure, as well as for women in labor who do not have access to epidural anesthesia. By the end of the year, 150 more operations with this analgesic are planned.
The launch of the new drug is part of a systematic effort to expand the range of domestic anesthetic drugs used for complex pain therapy and surgical treatment. This was stated to Izvestia by Denis Protsenko, Director of the MMCC Kommunarka, chief freelance specialist in anesthesiology and Intensive Care at the Moscow City Department of Health, Head of the Department of Anesthesiology and Intensive Care at the Pirogov Russian National Research Medical University.
— Russian doctors have gained access to a modern anesthetic drug included in international standards of treatment. Before it appeared, combined narcotic drugs were used to provide general anesthesia," he said.
According to Denis Protsenko, the availability of the drug is critically important for ensuring the country's drug safety, as "its use is necessary for complex and lengthy surgical procedures, including emergency ones." And also for patients suffering from diseases of the liver, kidneys and cardiovascular system.
How an analgesic works
Remifentanil is characterized by high-quality general anesthesia and controllability of withdrawal from it, providing rapid induction (achieving a state of anesthesia) and a short recovery period, Denis Protsenko said.
Alexey Ovechkin, Professor of the Department of Anesthesiology and Intensive Care at Sechenov University, explained that this is an ultrashort opioid analgesic new to Russia.
"It can be used in intensive care units, including in patients undergoing mechanical ventilation and in patients undergoing cardiac surgery," he said.
Lev Krichevsky, professor of the Department of Anesthesiology and Intensive Care at the Russian Medical Academy of Continuing Professional Education, called the new anesthetic a long-awaited drug, especially in cardioanesthesiology.
— This is a controlled drug, focused on early activation. This is a drug that is easy to regulate for its direct and adverse side effects," he clarified.
Cardioanesthesiologist Kirill Gruzdev agreed that doctors had been waiting for a long time for the opportunity to use this drug in cardiac surgery. In addition, it can be useful for spinal surgery and cranial trepanation.
The expert emphasized that this medicine is easily tolerated by patients and, unlike other anesthetics, can be used for patients with impaired liver and kidney functions.
"The drug is not metabolized in the liver, but in the muscles and blood plasma," he clarified.
The new drug can be used in the clinic, general anesthesia, and intensive care units, said Vladimir Nikoda, head of the Intensive Care Unit at the Russian Scientific Surgery Center named after Academician B.V. Petrovsky.
— Its important advantage is its controllability to short actions and the predictability of the effect, — he noted.
At the same time, remifentanil is a drug that requires not just knowledge from a doctor, but experience, Omar Zhashuev, head of the Department of anesthesiology and intensive care at the Euroonco clinic in St. Petersburg, told Izvestia.
"The introduction of the domestic version will reduce the financial burden on clinics, but the key question is whether regional medical institutions are ready to provide staff training," he argues. — If anesthesiologists master the subtleties of dosing, the demand for this drug may increase significantly. But if you treat it like a regular opioid, the risks of complications will increase.
According to the expert, there are cases in world practice when patients suffered short-term respiratory arrest due to incorrect adjustment of the infusion pump.
Previously, only imported analogues were used in Russia, for example, Ultima manufactured by Glaxo Wellcome Operations, Omar Zhashuev recalled. According to him, remifentanil is used in 15-20% of complex operations where high precision anesthesia is required.
— In cardiac surgery — in 45-50% of operations, in neurosurgery — in 35-40%, in plastic surgery — in 20-25% of cases, in traumatology — in 10-15%, — he specified.
This is about 5-7 thousand operations per year in large federal centers in Moscow, St. Petersburg and Novosibirsk, Omar Zhashuev emphasized. The introduction of a domestic drug can increase this figure by reducing costs and eliminating logistical risks, he is confident.
How many anesthetics are on the market now
In recent years, there has been a positive trend in the registration of domestic medicines, despite external challenges, the Ministry of Health told Izvestia.
"Currently, the regulation of the introduction of medicines to the market has been adapted, among other things, to innovative drugs that are in demand by the healthcare system to help patients suffering from life—threatening and disabling diseases," the ministry's press service said in a response.
According to the automated information system of Roszdravnadzor, for the release of medicines into civilian circulation for several years there has been a stable ratio of foreign (30%) and domestic (70%) medicines.
Anesthesia is the most complex area of medicine, where there are a huge number of nuances, and the set of drugs varies depending on the age category and situation, Nikolai Bespalov, executive director of RNC Pharma, explained to Izvestia. According to him, in addition to anesthetics, muscle relaxants and gas mixtures can also be used.
He clarified that there are two types of drugs for general anesthesia: inhalation and parenteral (injectable).
"Remifentanil belongs to parenteral drugs, and so far there have been no direct analogues of this product in our country," the expert emphasized.
According to RNC Pharma, the market volume of parenteral drugs for general anesthesia from January to September 2025 amounted to 4.8 million packages. Compared to the same period in 2024, the indicator increased by about 10% in physical terms. Last year, there was an increase of 13% relative to 2023.
The market for anesthesia drugs is quite narrow, Nikolai Bespalov noted.
— Before the advent of remifentanil, the total range consisted of only four active ingredients from six manufacturers. Three companies account for the main market share — Fersenius (about 23% of the market in packages), Binergy (about 19%) and the Moscow Endocrine Plant (34%)," he stressed.
Nikolay Bespalov added that the Moscow Endocrine Plant is the main player in the market. According to him, the company now has the widest range: it produces four out of five drugs.
According to the Cursor analytical company, no foreign drug with remifentanil was purchased through government procurement, and the domestic drug began to be sold in 2025. The volume of its government purchases as of the end of October this year is almost 14.6 thousand packages.
The company noted that drugs based on fentanyl can be considered an analogue of the drug with remifentanyl. Currently, only the Moscow Endocrine Plant and the State Plant of Medical Preparations have an indefinite registration certificate for such drugs. Although previously it was also owned by foreign companies — among them, for example, were Takeda, Johnson & Johnson, Gideon Richter and Sandoz.
According to the analytical company DSM Group, in 2024, the state purchased 3.5 million packages of anesthetics. In January–September 2025 — 2.4 million packages. Of these, in 2024, the share of localized was 72%, in January–September of this year — 89%. 445.6 thousand packages of narcotic anesthetics were purchased directly from January to September 2024, and 550.7 thousand packages for the same period in 2025.
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