pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2026-14-3-248-282pmedpharm-1895Research ArticleОБЗОРЫREVIEWОригинальные лекарственные препараты, одобренные Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов (Центр оценки и исследований лекарственных средств) в 2025 годуOriginal drug products approved by the Food and Drug Administration (Center for Drug Evaluation and Research) in 2025https://orcid.org/0000-0002-1116-3425КуркинД. В.KurkinD. V.

доктор фармацевтических наук, доцент, директор Научно-образовательного института фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России; профессор кафедры клинической фармакологии и интенсивной терапии, ФГБОУ ВО ВолгГМУ Минздрава России.

1. Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

2. Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

Doctor of Sciences (Pharmacy), Assistant Professor, Director of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine; Professor of the Department of Clinical Pharmacology and Intensive Care of the Volgograd State Medical University.

1. 4 Dolgorukovskaya Str., Moscow, Russia, 127006.

2. 1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

Strannik986@mail.ruhttps://orcid.org/0000-0002-7398-2186ОсадченкоН. А.OsadchenkoN. A.

кандидат медицинских наук, старший научный сотрудник лаборатории «Оценки технологий здравоохранения и клинико-экономической экспертизы», Научно-образовательный институт фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России. 

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

Candidate of Sciences (Medicine), Senior researcher of the Laboratory of Health Technology Assessment and Clinical and Economic Expertise of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine. 

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

n.a.osadchenko@gmail.comhttps://orcid.org/0000-0002-0270-2888ГалкинаД. А.GalkinaD. A.

кандидат фармацевтических наук, доцент кафедры медицинской и фармацевтической химии, Научно-образовательного института фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России.

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

Candidate of Pharmaceutical Sciences, Assistant Professor of the Department of Medical and Pharmaceutical Chemistry, Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine.

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

skretti@hotmail.comhttps://orcid.org/0000-0003-4694-3066БакулинД. А.BakulinD. A.

кандидат медицинских наук, руководитель Межкафедрального научно-образовательного центра фармации, Научно-образовательный институт фармации им. К.М. Лакина ФГБОУ ВО «Российский университет медицины» Минздрава России. 

Россия, 127006, г. Москва, ул. Долгоруковская д. 4. 

Candidate of Sciences (Medicine), Head of the Interdepartmental Scientific and Educational Center of Pharmacy of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine. 

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

mbfdoc@gmail.comhttps://orcid.org/0009-0007-7599-8353УстякинаЮ. Г.UstyakinaYu. G.

студент 3 курса лечебного факультета, Научно-образовательный институт фармации им. К.М. Лакина ФГБОУ ВО «Российский университет медицины» Минздрава России. 

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

a 3rd year student of the Faculty of Medicine of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine. 

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

korolparketa.ju@gmail.comВоскресенскийС. А.VoskresenskyS. A.

кандидат биологических наук, научный сотрудник, НЦИЛС ФГБОУ ВО ВолгГМУ Минздрава России.

Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

Candidate of Sciences (Biology), research fellow of Scientific Center for Innovative Medicines, Volgograd State Medical University.

1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

Voskresenskiy_1983@mail.ruhttps://orcid.org/0009-0001-5116-2240МакароваА. Р.MakarovaA. R.

научный сотрудник научно-исследовательской лаборатории экономики и фармации, Научно-образовательный институт фармации им. К.М. Лакина ФГБОУ ВО «Российский университет медицины» Минздрава России. 

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

researcher of the Research Laboratory of Economics and Pharmacy, Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine.

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

agliulova34@gmail.comhttps://orcid.org/0000-0002-7311-4549ШаталоваО. В.ShatalovaO. V.

доктор медицинских наук, профессор кафедры клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России. 

Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

Doctor of Sciences (Medicine), Professor of the Department of Clinical Pharmacology and Intensive Care of the Volgograd State Medical University. 

1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

shov_med@mail.ruhttps://orcid.org/0000-0002-6997-1601СтрыгинА. В.StryginA. V.

кандидат медицинских наук, доцент, заведующий кафедрой фундаментальной биологии и медицины, ФГБОУ ВО ВолгГМУ Минздрава России.

Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

 

Candidate of Sciences (Medicine), Assistant Professor, Head of the Department of Fundamental Biology and Medicine of the Volgograd State Medical University. 

1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

drumsav@mail.ruhttps://orcid.org/0000-0002-0258-4092ПетровВ. И.PetrovV. I.

доктор медицинских наук, профессор, академик РАН, заведующий кафедрой клинической фармакологии и интенсивной терапии, ФГБОУ ВО ВолгГМУ Минздрава России; главный внештатный специалист — клинический фармаколог Министерства здравоохранения РФ; заслуженный деятель науки РФ; заслуженный врач РФ. 

Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

 

Doctor of Sciences (Medicine), Professor, Head of the Department of Clinical Pharmacology and Intensive Care of the Volgograd State Medical University; Chief freelance specialist — Clinical Pharmacologist of the Ministry of Health of the Russian Federation; Honored Scientist of the Russian Federation; Honored Doctor of the Russian Federation; Academician of the Russian Academy of Sciences. 

1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

brain@sprintnet.ruhttps://orcid.org/0000-0003-4333-322XМаринчеваО. В.MarinchevaO. V.

кандидат фармацевтических наук, заведующий лабораторией экономики и фармации, Научно-образовательный институт фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России.

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

Candidate of Sciences (Pharmacy), Head of the Laboratory of Economics and Pharmacy of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine. 

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

ovivanova134@mail.ruhttps://orcid.org/0000-0002-6416-0500ГорбуноваЮ. В.GorbunovaYu. V.

кандидат фармацевтических наук, заведующий лабораторией фармации, фармакологии, фармакогнозии, фармацевтической технологии и химии, Научно- образовательный институт фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России. 

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

Candidate of Sciences (Pharmacy), Head of the Laboratory of Pharmacy, Pharmacology, Pharmacognosy, Pharmaceutical Technology and Chemistry of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine.

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

yvgorbunova@yandex.ruhttps://orcid.org/0000-0003-1571-9301КоряноваК. Н.KoryanovaK. N.

кандидат фармацевтических наук, доцент кафедры фармации ФПО ПМФИ – филиала ФГБОУ ВО ВолгГМУ Минздрава России; доцент кафедры фармации, общей фармакологии и фармацевтического консультирования ФГБОУ ДПО РМАНПО Минздрава России. 

1. Россия, 357532, г. Пятигорск, пр-кт Калинина, д. 11.

2. Россия, 125993, г. Москва, ул. Баррикадная, д. 2/1, стр. 1.

Candidate of Sciences (Pharmacy), Assistant Professor of the Department of Pharmacy, Faculty of Postgraduate Education of the Pyatigorsk Medical and Pharmaceutical Institute — branch of Volgograd State Medical University; Assistant Professor of the Department of Pharmacy, General Pharmacology and Pharmaceutical Consulting of the Russian Medical Academy of Continuing Professional Education. 

1. 11 Kalinin Ave., Pyatigorsk, Russial, 357532.

2.  2/1 Barrikadnaya Str., bldg. 1, Moscow, Russia, 125993.

kskor-16@mail.ruhttps://orcid.org/0000-0001-7778-8391МищенкоЕ. С.MishchenkoE. S.

кандидат фармацевтических наук, доцент кафедры токсикологической и аналитической химии ПМФИ – филиала ФГБОУ ВО ВолгГМУ Минздрава России. 

Россия, 357532, г. Пятигорск, пр-кт Калинина, д. 11.

Candidate of Pharmaceutical Sciences, Assistant Professor of the Department of Toxicological and Analytical Chemistry of the Pyatigorsk Medical and Pharmaceutical Institute — branch of Volgograd State Medical University.

11 Kalinin Ave., Pyatigorsk, Russial, 357532.

ekaterina-mischenko1809@mail.ruhttps://orcid.org/0009-0002-7998-2352ГадаевИ. Ш.GadaevI. Sh.

студент 4 курса стоматологического факультета ФГБОУ ВО СтГМУ Минздрава России.

Россия, 355017, г. Ставрополь, ул. Мира, д. 310.

4 year student at the Faculty of the Stavropol State Medical University.

310 Mir Str., Stavropol, Russia, 355017.

ilyas.gadayev.03@mail.ruhttps://orcid.org/0000-0002-7806-2805ЩербаковаЛ. И.ShcherbakovaL. I.

кандидат фармацевтических наук, доцент, заместитель директора по учебно-воспитательной работе, заведующий кафедрой химии ПМФИ – филиала ФГБОУ ВО ВолгГМУ Минздрава России. 

Россия, 357532, г. Пятигорск, пр-кт Калинина, д. 11.

Candidate of Sciences (Pharmacy), Assistant Professor, Deputy Director for Educational Affairs, Head of the Department of Chemistry, Pyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University. 

11 Kalinin Ave., Pyatigorsk, Russial, 357532.

shcherbakovali@mail.ruhttps://orcid.org/0009-0002-9522-7605ДьяковаИ. Н.DyakovaI. N.

кандидат фармацевтических наук, доцент, заведующий кафедрой биологии и физиологии, и.о. декана факультета последипломного образования ПМФИ – филиала ФГБОУ ВО ВолгГМУ Минздрава России.

Россия, 357532, г. Пятигорск, пр-кт Калинина, д. 11.

 

 

Candidate of Sciences (Pharmacy), Assistant Professor, Head of the Department of Biology and Physiology, Acting Dean of the Faculty of Postgraduate Education, Pyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University. 

11 Kalinin Ave., Pyatigorsk, Russial, 357532.

irochkadyakova@mail.ruhttps://orcid.org/0000-0002-7119-3546МорковинЕ. И.MorkovinE. I.

кандидат медицинских наук, доцент, заместитель директора по научной работе, Научно-образовательный институт фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России.

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

Candidate of Sciences (Medicine), Assistant Professor, Deputy Director for Scientific Work of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine. 

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

e.i.morkovin@gmail.comhttps://orcid.org/0000-0001-6586-7148ШуваеваА. С.ShuvaevaA. S.

младший научный сотрудник, Научно-образовательный институт фармации им. К.М. Лакина, ФГБОУ ВО «Российский университет медицины» Минздрава России. 

Россия, 127006, г. Москва, ул. Долгоруковская д. 4.

 

junior researcher of the Scientific and Educational Institute of Pharmacy n.a. K.M. Lakin, Russian University of Medicine. 

4 Dolgorukovskaya Str., Moscow, Russia, 127006.

annaxo@mail.ru1. Федеральное государственное бюджетное образовательное учреждение высшего образования «Российский университет медицины» Министерства здравоохранения Российской Федерации. 2. Федеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.Россия1. Russian University of Medicine. 2. Volgograd State Medical University.Russian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Российский университет медицины» Министерства здравоохранения Российской Федерации.РоссияRussian University of Medicine.Russian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.РоссияVolgograd State Medical University.Russian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Российский университет медицины» Министерства здравоохранения Российской ФедерацииРоссияRussian University of Medicine.Russian Federation1. Пятигорский медико-фармацевтический институт – филиал федерального государственного бюджетного образовательного учреждения высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации. 2. Федеральное государственное бюджетное образовательное учреждение дополнительного профессионального образования «Российская медицинская академия непрерывного профессионального образования» Министерства здравоохранения Российской Федерации.Россия1. Pyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University. 2. Russian Medical Academy of Continuous Professional Education.Russian FederationПятигорский медико-фармацевтический институт – филиал федерального государственного бюджетного образовательного учреждения высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.РоссияPyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University.Russian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Ставропольский государственный медицинский университет» Министерства здравоохранения Российской Федерации.РоссияStavropol State Medical University.Russian Federation202618062026143248282Copyright © Куркин Д.В., Осадченко Н.А., Галкина Д.А., Бакулин Д.А., Устякина Ю.Г., Воскресенский С.А., Макарова А.Р., Шаталова О.В., Стрыгин А.В., Петров В.И., Маринчева О.В., Горбунова Ю.В., Корянова К.Н., Мищенко Е.С., Гадаев И.Ш., Щербакова Л.И., Дьякова И.Н., Морковин Е.И., Шуваева А.С., 20262026Куркин Д.В., Осадченко Н.А., Галкина Д.А., Бакулин Д.А., Устякина Ю.Г., Воскресенский С.А., Макарова А.Р., Шаталова О.В., Стрыгин А.В., Петров В.И., Маринчева О.В., Горбунова Ю.В., Корянова К.Н., Мищенко Е.С., Гадаев И.Ш., Щербакова Л.И., Дьякова И.Н., Морковин Е.И., Шуваева А.С.Kurkin D.V., Osadchenko N.A., Galkina D.A., Bakulin D.A., Ustyakina Y.G., Voskresensky S.A., Makarova A.R., Shatalova O.V., Strygin A.V., Petrov V.I., Marincheva O.V., Gorbunova Y.V., Koryanova K.N., Mishchenko E.S., Gadaev I.S., Shcherbakova L.I., Dyakova I.N., Morkovin E.I., Shuvaeva A.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/1895

Ежегодный обзор новых препаратов, одобренных FDA, представляет собой важный инструмент для анализа современных тенденций в фармакологии и медицине, отражая прогресс в лечении сложных заболеваний, включая онкологические патологии, орфанные болезни и инфекционные процессы. Статья направлена на информирование медицинских специалистов и фармакологов о современных тенденциях в разработке и регистрации инновационных лекарственных препаратов в 2025 году.

Цель

Цель. Обобщить и систематизировать данные о новейших лекарственных препаратах, вышедших на рынок в 2025 году, а также проанализировать механизмы их действия.

Материалы и методы

Материалы и методы. Представленные данные взяты из открытых источников и дополнены результатами отдельных исследований, посвящённых изучению новых механизмов и подходов в терапии. Основной список новых лекарственных препаратов и вводная информация о них взяты из отчета Управления по санитарному надзору за качеством пищевых продуктов и медикаментов (FDA) — «Novel Drug Approvals for 2025».

Результаты

Результаты. В 2025 году FDA одобрено 46 лекарственных препаратов, среди которых 31 — это малые молекулы и 15 — макромолекулы. Среди препаратов из первой группы в онкологии применяют 11 (24% от всех новых препаратов и 35% от всех новых малых молекул), 2 — иммунотропные и 2 для применения в кардиологии. Большая часть (16 препаратов) относится к разрозненным группам препаратов. Среди биопрепаратов большую часть составили моноклональные антитела для лечения неонкологических заболеваний — 6 (13% от всех и 40% от биопрепаратов) и моноклональные антитела для лечения онкологических заболеваний — 5 (11% от всех и 33% от биопрепаратов). Препараты на основе нуклеиновых кислот и белковые молекулы, кроме антител, составили 3 (7% от всех и 20% от биопрепаратов) и 1 (2% от всех и 7% от биопрепаратов) соответственно.

Заключение

Заключение. Большая доля биопрепаратов среди вновь зарегистрированных лекарственных препаратов в 2025 году подчёркивает динамичное развитие фармацевтической отрасли и ее ориентацию на персонализированную медицину и биотехнологии. Терапия, основанная на mAb, взаимодействующих с рецепторами, а также иммунотерапия, основанная на новых открытых механизмах противоопухолевого иммунитета, занимает весомучасть в структуре оригинальных препаратов. Остаётся актуальным поиск новых рациональных комбинаций антибиотиков. Большую часть рынка оригинальных препаратов все еще составляют малые молекулы, среди которых появляются лекарственные средства — лиганды новых мишеней и олигонуклеотидные последовательности. Обзор составлен для ознакомления медицинских специалистов и фармакологов с современными тенденциями в регистрации оригинальных препаратов и в терапии злокачественных образований, а также орфанных болезней.

The annual review of new drugs approved by the FDA is an important tool for analyzing current trends in pharmacology and medicine, reflecting progress in the treatment of complex diseases, including oncological pathologies, orphan diseases, and infectious processes. The article aims to inform medical specialists and pharmacologists about current trends in the development and registration of innovative medicinal products in 2025.The aim. To summarize and systematize data on the latest medicinal products launched in 2025, and to analyze their mechanisms of action.

Materials and methods

Materials and methods. The presented data are taken from open sources and supplemented by the results of individual studies aimed to the investigate new mechanisms and approaches in therapy. The main list of new medicines and introductory information about them are taken from the report of the Food and Drug Administration (FDA) — "Novel Drug Approvals for 2025.

Results

Results. In 2025, the FDA approved 46 drugs, of which 31 were small molecules and 15 were macromolecules. Among the drugs in the first group, 11 (24 % of all new drugs and 35 % of all new small molecules) are used in oncology, 2 are immunotropic, and 2 are for cardiology. The majority (16 drugs) belong to miscellaneous drug groups. Among biologicals, the largest portion consisted of monoclonal antibodies for the treatment of non-oncological diseases — 6 (13 % of all and 40 % of biologicals) and monoclonal antibodies for the treatment of oncological diseases — 5 (11 % of all and 33 % of biologicals). Nucleic acid-based drugs and protein molecules, excluding antibodies, accounted for 3 (7 % of all and 20 % of biologicals) and 1 (2 % of all and 7 % of biologicals) respectively.

Conclusion

Conclusion. The significant proportion of biopharmaceuticals among newly registered drug products in 2025 highlights the dynamic development of the pharmaceutical industry and its focus on personalized medicine and biotechnology. Therapy based on mAbs interacting with receptors, as well as immunotherapy based on newly discovered mechanisms of anti-tumor immunity, occupies a substantial part of the structure of original drugs. The search for new rational antibiotic combinations remains relevant. Small molecules still constitute the largest share of the original drug market, among which drug substances — ligands of new targets and oligonucleotide sequences are emerging. This review is compiled for medical specialists and pharmacologists to familiarize them with current trends in the registration of original drugs and in the therapy of malignant neoplasms, as well as orphan diseases.

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The authors declare that there are no conflicts of interest present.