Anticipated advancements in obesity, oncology, gene therapy
and other areas poised to revolutionize patient care
LONDON, Jan. 8, 2025
/PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading
global provider of transformative intelligence, today announced the
release of the twelfth annual Drugs to Watch™ report, a trusted
guide to the therapies poised to redefine the future of
healthcare. This year, the highly anticipated resource highlights
11 drugs projected to achieve blockbuster status or revolutionize
treatment paradigms within five years. Since its inception, Drugs
to Watch has identified over 98 transformative therapies, cementing
its role as an essential resource for navigating the ever-evolving
pharmaceutical landscape.
This year's report, powered by insights from the Clarivate
Cortellis intelligence suite of products, highlights 11 therapies
that have recently launched or are set to debut in 2025. These
innovations, addressing critical challenges in areas such as
obesity, oncology, and gene therapy, are forecast to achieve
blockbuster sales by 2030 or dramatically improve patient outcomes
on a global scale. The report also explores pivotal trends shaping
the industry, including the surging demand for obesity treatments,
the transformative potential of gene editing, and the growing
impact of regulatory innovation.
The report offers an in-depth analysis of the chronic disease
market in Mainland China, spotlighting five therapies expected to
exceed $1 billion in annual sales
over the next five years or deliver transformative outcomes for
patients. It also explores critical topics shaping global
healthcare, including regulatory advancements, the role of
radiopharmaceutical theranostics in oncology, and the growing use
of real-world data (RWD) and patient-reported outcomes (PROs) to
drive health equity and enhance regulatory submissions.
Henry Levy, President, Life
Sciences & Healthcare, Clarivate,
remarked: "Innovation in the life sciences is reaching
unprecedented heights, and this year's Drugs to Watch™ report once
again demonstrates the industry's ability to deliver therapies that
address unmet medical needs and challenge existing paradigms of
care. At Clarivate, we take pride in the precision and reliability
of our predictions—last year, we identified 13 molecules as Drugs
to Watch, with 12 already approved and launched and one poised for
launch. This track record reflects the strength of our
comprehensive data and deep expertise. By continuing to provide
actionable insights, we empower the sector to navigate
opportunities, overcome challenges and drive progress in advancing
global health."
Mike Ward, Global Head of
Thought Leadership, Life Sciences & Healthcare, Clarivate,
stated: "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."
The 2025 Drugs to Watch™ report highlights key trends
reshaping the life sciences landscape, emphasizing the
transformative impact of emerging technologies and therapeutic
breakthroughs. Advances in AI and machine learning are streamlining
drug discovery, clinical trials, and real-world data integration,
enabling precision medicine approaches. The obesity market is
undergoing a revolution driven by next-generation GLP-1 therapies,
while radiopharmaceutical theranostics are redefining cancer
treatment with a "see it and treat it" paradigm. Gene editing
technologies are unlocking new opportunities in personalized
medicine, and evolving regulatory frameworks are fostering greater
emphasis on patient-reported outcomes and health equity. Together,
these trends showcase the sector's resilience and its ability to
navigate challenges while driving innovation to improve patient
care worldwide.
This year's drugs to watch exemplify the fusion of innovation
and dedication to advancing patient care in an increasingly complex
healthcare ecosystem. The Drugs to Watch™ 2025 list
include:
AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk |
Type 1 and type 2 diabetes mellitus
AWIQLI®, the first
once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and
Japan. Its weekly dosing offers a
significant advantage over daily basal insulin, potentially
reducing the treatment burden for patients with type 1 or type 2
diabetes (T1DM and T2DM).
CagriSema (cagrilintide + semaglutide) developed by Novo
Nordisk | Obesity and type 2 diabetes
mellitus
CagriSema, combining cagrilintide, a
long-acting amylin analog, with semaglutide, promises superior
efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide
(MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This
next-generation GLP-1 therapy leverages the benefits of GLP-1s,
such as enhanced insulin secretion and appetite reduction, while
incorporating amylin's effects, including slowed glucose absorption
and release. If approved, CagriSema will be the first fixed-dose
combination of amylin and GLP-1 receptor agonists in the obesity
and T2DM markets.
COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol
Myers Squibb | Schizophrenia and psychosis related to Alzheimer's
disease
Amid setbacks for emerging schizophrenia
treatments, the approval of COBENFY marks a transformative
milestone as the first drug in over 30 years with a novel mechanism
of action for treating schizophrenia. Combining xanomeline and
trospium, COBENFY selectively targets M1 and M4 receptors, rather
than traditional dopamine pathways, while minimizing cholinergic
side effects. While further data is needed to assess its
effectiveness in Alzheimer's disease-related psychosis, COBENFY
shows strong commercial potential if proven effective in treating
AD-related hallucinations and delusions.
EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and
Almirall | Atopic dermatitis
EBGLYSS™, the third biologic
targeting IL-13 for atopic dermatitis, follows DUPIXENT®
(dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less
frequent dosing, more selective IL-13 inhibition, and strong
efficacy and safety data position it as a likely first-line
treatment for moderate-to-severe atopic dermatitis when topical
corticosteroids are inadequate.
Fitusiran developed by Alnylam® Pharmaceuticals Inc and
Sanofi | Hemophilia A and B
Fitusiran, shown to be
effective in phase 3 trials for both hemophilia A and B, regardless
of inhibitor status, has the potential to offer a new approach to
hemophilia treatment. This small interfering RNA (siRNA) therapy
works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels,
promoting thrombin generation, and helping to rebalance hemostasis
to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc
conjugate technology, fitusiran could become the first
antithrombin-lowering therapy based on a double-stranded RNA
molecule, pending approval.
GSK-3536819 (MenABCWY) developed by GSK plc |
Meningococcus
GSK plc's GSK-3536819 vaccine candidate, a
5-in-1, first-generation formulation, targets the five groups of
Neisseria meningitidis (A, B, C, W, and Y) responsible for
most invasive meningococcal disease (IMD) cases worldwide. It
combines the antigenic components of GSK's licensed meningococcal
vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have
established efficacy and safety profiles.
IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell
lung cancer (SCLC)
IMDELLTRA™ is a first-in-class
immunotherapy for extensive-stage small cell lung cancer (ES-SCLC).
Using Amgen's bispecific T cell engager (BiTE®) molecules, it
targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to
attack and lyse the tumor. DLL3 is expressed on the surface of
SCLC cells in more than 85% of patients but is minimally expressed
on healthy cells making it an attractive target. This
mechanism positions IMDELLTRA as a potential standard of care for
previously treated ES-SCLC.
mRESVIA (mRNA-1345) developed by Moderna Inc | RSV
With its U.S. FDA approval in May
2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in
Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines
currently available for adults ages 60 years and older, helping
further support the public health initiative to reduce the
RSV-related disease burden. Even with available vaccines, RSV
infections continue to be a public health concern, particularly for
infants and older adults (65 years and older).
SEL-212 developed by Sobi® and Cartesian Therapeutics
Inc/Selecta Biosciences Inc | Gout
SEL-212 is a novel,
once-monthly treatment combining pegylated uricase (pegadricase;
SEL-037) with ImmTOR™, an immune tolerance technology designed to
inhibit the formation of anti-drug antibodies (ADAs). For this
application, ImmTOR consists of SEL-110.36, an inhibitor of
uricase-specific ADA. This approach may help overcome the
limitations of reduced efficacy and tolerability seen with other
biologic treatments, such as KRYSTEXXA® (pegloticase), in patients
with chronic gout.
Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer
Inc | Breast cancer
A global collaboration between Arvinas
Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis
Targeting Chimera (PROTAC®) protein degrader on the market.
Designed to target and degrade the estrogen receptor (ER) protein,
early studies suggest PROTAC-induced degradation is more complete
than with oral selective estrogen receptor degraders (SERDs). This
offers potential for overcoming endocrine resistance in breast
cancer. Label expansions, including combination with IBRANCE®
(palbociclib), are being explored.
Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal
cancer, renal cell carcinoma and squamous cell carcinoma of head
and neck
Zanzalintinib is a third-generation oral tyrosine
kinase inhibitor targeting VEGF receptors, MET, and TAM kinases
involved in tumor growth and immunosuppression. Currently in phase
3 trials for non-clear-cell renal cell carcinoma (nccRCC),
colorectal cancer (CRC) and squamous cell carcinoma of the head and
neck (SCCHN), the company anticipates one potential zanzalintinib
launch per year starting as early as 2026. Compared to CABOMETYX®
(cabozantinib), zanzalintinib may offer benefits, including
approval for nccRCC histology and a broader patient population.
Access the Drugs to Watch 2025 report from
Clarivate, here.
For more Drugs to Watch updates and analyses throughout the
year, visit the Drugs to Watch web page and follow Clarivate for
Life Sciences & Healthcare on LinkedIn and X.
Join the conversation, using #DrugstoWatch.
To learn more about how Clarivate can help healthcare companies
inform and shape the drug discovery, development and delivery
process, visit here.
Methodology for the Clarivate Drugs to Watch 2025
Report
To identify this year's Drugs to Watch, Clarivate
drew from the expertise of over 160 analysts covering hundreds
of diseases, drugs and markets, along with 11 integrated data sets
that span the R&D and commercialization lifecycle,
including: Cortellis Competitive
Intelligence™, Disease Landscape &
Forecast, Epidemiology Intelligence, BioWorld™, Cortellis
Regulatory Intelligence™, Drug Timeline & Success
Rates, Cortellis Clinical Trials Intelligence™, Cortellis
Deals Intelligence™, Access & Reimbursement
payer studies, Clarivate Real-World Data and
Analytics, Web of Science™, Derwent
Innovation™, and other industry sources including
biopharma company press releases, filings and peer-reviewed
publications. Candidate drugs in phase 2 or phase 3 trials, at
pre-registration or registration stage, or already launched in 2024
were selected for analysis, including both novel treatments and
already-marketed drugs pursuing new indications that could be
particularly impactful. Drugs launched prior to 2024 were excluded.
The dataset was filtered for drugs that had total forecast sales
of $1 billion or more by 2030. Clarivate experts and
analysts evaluated each drug in its individual context, based on
factors such as expected approval or launch dates, competitive
landscape, regulatory status, trial results, market dynamics and
other key factors, and added novel drugs that, while likely to fall
short of blockbuster status, are poised to be therapeutic
game-changers.
Please note that Clarivate analysts generated the data shown in
this report prior to December 31, 2024. The Drugs to Watch
2025 Report and the treatments referenced in this release are based
on Clarivate's current expectations per existing data, but actual
results derived from the drugs named in the report and here may
differ significantly.
Clarivate is committed to comprehensively supporting customers
across the entire drug, device and medical technology lifecycles to
advance human health. By combining patient journey data,
therapeutic area expertise, artificial intelligence and analytics
in ways that unlock hidden insights, data-driven decisions and
accelerating innovation, Clarivate's end-to-end research
intelligence is designed to enable customers to make informed
evidence-based decisions.
About Clarivate
Clarivate™ is a leading global provider of transformative
intelligence. We offer enriched data, insights & analytics,
workflow solutions and expert services in the areas of Academia
& Government, Intellectual Property and Life Sciences &
Healthcare. For more information, please
visit www.clarivate.com.
Media Contact:
Catherine
Daniel
Director, External Communications, Life Sciences &
Healthcare
newsroom@clarivate.com
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