Potential blockbuster drugs to watch in 2025

Eleven medicines, covering key areas such as gene therapy, as well as drugs for obesity and oncology, are anticipated to attain blockbuster status or be therapeutic game-changers globally within five years to 2030, according to the 2025 edition of the Drugs to Watch ™ report.

These therapies are either newly launched or are set to be marketed in 2025, Clarivate explained.

Key therapeutic trends for 2025

While 2024 saw major developments in obesity treatment driven by next-generation GLP-1 therapies, Clarivate remarked that radiopharmaceutical theranostics are “redefining” cancer treatment with a “see it and treat it” paradigm. Moreover, gene editing technologies are expected to innovate personalised medicine in 2025, research in the Drugs to Watch report stated.

On the regulatory side, the report highlighted the growing impact of regulatory innovation and the industry’s increased use of real-world data (RWD) as a tool to improve regulatory submissions. In addition, evolving regulatory frameworks are putting more emphasis on patient-reported outcomes and health equity, the authors noted.

EPR covered this report in 2023, highlighting promising medicines such as lecanemab for Alzheimer’s and an innovative gene therapy to treat haemophilia A. These treatments both achieved major developmental milestones in 2023.

Potential blockbuster drugs to watch in 2023

“Last year [2024], we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch,” Henry Levy, President, Life Sciences & Healthcare, Clarivate reflected.

Going forward, “2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year’s report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities,” Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate explained.

Drugs to watch 2025 – what medicines are included in the report?

Novo Nordisk’s obesity and diabetes drugs

AWIQLI^® (LAI 287; insulin icodec)

AWIQLI, the first once-weekly, subcutaneous insulin, is marketed in Australia, Canada, the EU, Mainland China, and Japan. The drug provides easier dosing compared to standard daily basil insulin for type 1 and type 2 diabetes mellitus. In its March 2024 meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended AWIQLI for adults with this condition.

CagriSema (cagrilintide + semaglutide)

By combining cagrilintide, a long-acting amylin analog, with semaglutide, CagriSema has potential for superior efficacy over semaglutide (OZEMPIC/WEGOVY^®) and tirzepatide (MOUNJARO/ZEPBOUND^®) in treating obesity and type 2 diabetes, according to the research.

As a next-generation GLP-1 therapy, CagriSema provides not only enhanced insulin secretion and appetite reduction, but also slowed glucose absorption and release. The report emphasised that the drug will be the first fixed-dose combination of amylin and GLP-1 receptor agonists for these diseases if approved.

Schizophrenia and psychosis linked to Alzheimer’s disease

COBENFY™ (KarXT; xanomeline-trospium)

Approval of Bristol Myers Squibb’s COBENFY represents a key milestone as the first schizophrenia drug in over three decades with a novel mechanism of action. The treatment targets an alternative pathway in the brain to traditional dopamine pathways, while minimising cholinergic side effects. The report cautioned that further data is needed to investigate its effectiveness in Alzheimer’s disease-related psychosis. However, COBENFY “shows strong commercial potential if proven effective” for these symptoms.

Atopic dermatitis

EBGLYSS™ (lebrikizumab)

Eli Lilly and Company and Almirall’s EBGLYSS, could be a first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate, the report predicted.

After DUPIXENT^® (dupilumab) and ADBRY^®/ADTRALZA^® (tralokinumab), EBGLYSS is the third biologic targeting IL-13 for atopic dermatitis, the research stated. Its benefits include “less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position”.

Haemophilia A and B

The small interfering RNA (siRNA) therapy Fitusiran from Sanofi and Alnylam^® Pharmaceuticals Inc, “could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule”. For example, it has shown efficacy in Phase III trials for both haemophilia A and B, regardless of inhibitor status, the report noted.

Vaccines

GSK-3536819 (MenABCWY)

The Drugs to Watch report included a first-generation vaccine from GSK. Its formulation targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease cases globally. GSK-3536819 candidate combines the antigenic components of GSK’s licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY).

mRESVIA (mRNA-1345)

Following approval by the US Food And Drug Administration (FDA) in May 2024, the respiratory syncytial virus (RSV) vaccine mRESVIA^® became available for adults aged 60 years old and over. RSV vaccines for this indication, AREXVY and ABRYSVO, are also featured in the Drugs to Watch report this year.

Breast cancer

Vepdegestrant (ARV-471)

Vepdegestrant, developed though a collobation between Pfizer Inc and Arvinas Inc, could become the first PROteolysis Targeting Chimera (PROTAC^®) protein degrader on the market. It has potential to overcome endocrine resistance in breast cancer, early clinical studies suggest, the report highlighted.

Data from the 2025 Drugs to Watch report was generated prior to 31 December 2024, Clarivate confirmed.