11 potential blockbuster drugs to watch in 2026

Innovation across therapeutic modalities has positioned 2026 as a defining year for the pharmaceutical industry. In its Drugs to Watch 2026 report, Clarivate highlights 11 therapies that have recently launched or are nearing key milestones and are poised to reshape treatment paradigms, improve patient outcomes, and in many cases achieve blockbuster status within five years. Blockbuster status — defined as annual sales exceeding $1 billion —  remains a key benchmark, but this year’s list also reflects how scientific ambition is increasingly paired with clinical and commercial precision.

More than 160 Clarivate analysts evaluated each drug, assessing factors such as expected approval or launch timing, competitive landscape, regulatory status, pivotal trial results, and other key dynamics.

A defining theme in this year’s report is the ongoing metabolic revolution. The global obesity drug market is projected to reach $150 billion by 2035, and the glucagon-like peptide-1 (GLP-1) receptor agonist class is entering a new phase of maturation. Topping the list is Eli Lilly’s orforglipron, an investigational oral GLP-1 RA designed to provide an alternative to injectable therapies in obesity and Type 2 diabetes. Next-generation metabolic agents aim to improve adherence, expand therapeutic reach, and differentiate beyond first-wave GLP-1 success.

Lilly has boosted its pre-launch inventory orforglipron, which awaits potential FDA approval. So far, the company has stockpiled approximately $1.5 billion of the pills. Among the factors Lilly considered, in deciding to build up a pre-launch inventory, were: orforglipron’s status in the regulatory approval process, potential impediments to the approval process, viability of commercialization, as well as market trends. CEO Dave Ricks has said it will be “easier” for Lilly to manufacture orforglipron at scale in the U.S. because it is an oral drug.

Beyond metabolic disease, the Clarivate report spans rare disorders, oncology, immunology, nephrology, and women’s health, underscoring the breadth of innovation advancing through late-stage pipelines. Collectively, these therapies reflect an industry continuing to push scientific boundaries while redefining standards of care across diverse patient populations.

The following therapies represent Clarivate’s top drugs to watch in 2026:

Orforglipron

Manufacturer: Eli Lilly

Indication: Overweight/obesity and Type 2 diabetes mellitus (T2DM)

Orforglipron is a once-daily oral, non-peptide, small-molecule GLP-1 receptor agonist being developed to treat obesity and T2DM. Clarivate’s Drugs to Watch 2026 report notes it being the first oral, non-peptide GLP-1 receptor agonist (RA) to reach Phase 3 trials, marking a significant advancement beyond injectable therapies. Phase 3 studies demonstrated clinically meaningful weight loss, including reductions of up to 12.4% in one trial, supporting regulatory submissions for obesity.

Top-line Phase 3 results show efficacy comparable or superior to existing GLP-1 therapies, while maintaining a safety profile consistent with injectable therapies. In the global Phase 3 ACHIEVE-2 and ACHIEVE-3 trials, all evaluated doses achieved superior HbA1c reduction compared with comparators in patients with T2DM.

As a non-peptide therapy, orforglipron does not require cold-chain storage, potentially simplifying manufacturing, distribution, and patient access. The company has already stockpiled approximately $548 million in pre-launch inventory, underscoring expectations for strong demand. The drug is also being evaluated for additional obesity-related conditions, including obstructive sleep apnea and hypertension. Regulatory submissions for T2DM are expected in the first half of 2026.

Retatrutide

Manufacturer: Eli Lilly

Indication: Overweight/obesity and Type 2 diabetes mellitus (T2DM).

Retatrutide is a triple agonist peptide targeting GLP-1, GIP, and glucagon receptors, enabling broader metabolic regulation than therapies targeting a single pathway. This multi-receptor approach is designed to deliver greater weight loss and metabolic control.

In Phase 2 trials, all participants achieved at least 5% weight loss, with approximately 25% of patients receiving the highest dose achieving weight reductions of 30% or greater. Safety and tolerability were consistent with the established GLP-1 class.

Head-to-head study of retatrutide against Ozempic in type 2 diabetes is notable, given that subcutaneous semaglutide is among the most effective GLP‑1 RAs for lowering HbA1c and promoting weight loss. Showing clear superiority over Ozempic in glycemic and weight outcomes could give retatrutide a meaningful competitive edge in the market.

Clarivate projects the drug could become a major growth driver in the obesity market after 2028, potentially shifting patients to newer therapies ahead of patent expirations for current market leaders.

Exdensur (depemokimab)

Manufacturer: GSK

Indication: Asthma

Exdensur is an ultra-long-acting monoclonal antibody targeting interleukin-5 (IL-5), administered via subcutaneous injection twice yearly for severe asthma. Its extended dosing interval represents a major shift from existing biologics that typically require monthly or bimonthly administration.

The biologic’s extended half-life has the potential to provide sustained inhibition of broad inflammatory functions and is being investigated in a variety of Type 2 inflammatory conditions. Exdensur is the first ultra-long-acting biologic evaluated in Phase 3 trials and was approved last December by the FDA to treat severe asthma with an eosinophilic phenotype. Pivotal Phase 3 studies of Exdensur all met their primary endpoints.

The asthma treatment market is forecast to significantly grow due to the increased uptake of biologics emphasizing a shift toward more personalized treatment of asthma, with long-acting therapies like Exdensur anticipated to improve adherence and reduce treatment burden. However, increasing competition and pricing pressures could influence long-term market dynamics.

Icotrokinra

Manufacturer: Johnson & Johnson

Indication: Plaque psoriasis 

Icotrokinra is an oral peptide therapy that selectively inhibits the interleukin-23 (IL-23) receptor, a key driver of inflammation in plaque psoriasis. It may become the first oral therapy specifically designed to block IL-23 signaling.

Positive results from four pivotal Phase 3 trials — ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 — supported regulatory submission, demonstrating the potential to position icotrokinra as a first-line oral treatment. If approved, it could offer a convenient alternative to injectable biologics.

Newer oral agents for moderate to severe plaque psoriasis, like icotrokinra, are expected to contribute to growth of patient share and sales, according to Clarivate’s report. The use of biologics and targeted oral therapies for moderate to severe disease is expected to increase, growing from 17.6% patient share in 2024 to 19.4% in 2034. 

Additionally, with the launch and uptake of icotrokinra and the current sales of SKYRIZI, IL-23 inhibitors are forecast to overtake all biological drug classes, due to their strong efficacy, more convenient dosing than IL-17 inhibitors and favorable safety profiles.

VOYXACT

Manufacturer: Otsuka Pharmaceutical

Indication: Immunoglobulin A nephropathy (IgAN)

VOYXACT is a monoclonal antibody targeting APRIL (A PRoliferation Inducing Ligand), a key protein involved in IgAN pathogenesis. As a self-administered subcutaneous injection every four weeks at home, it targets a key pathway in IgAN pathogenesis to reduce the production of IgA and galactose-deficient IgA1 (Gd-IgA1), which provide less substrate to form an immune complex.

It has demonstrated a robust efficacy profile in proteinuria reduction for IgAN, as well as having a well-established safety profile across dose ranges, according to Clarivate’s report. Due to its low-burden administration and superior efficacy profile, VOYXACT is expected to experience strong uptake.

It received breakthrough therapy designation by the FDA in February 2024, which was based on positive Phase 2 results, and a BLA submission in March 2025 was additionally supported by interim results from its pivotal phase 3 VISIONARY trial. The VISIONARY trial delivered impressive results at its interim analysis, with the most pronounced reduction in proteinuria reported to date in IgAN Phase 3 trials. 

The therapy’s strong efficacy and convenient administration could drive significant levels of adoption, although increasing competition in IgAN treatment may shape its ultimate market impact.

Tolebrutinib

Manufacturer: Sanofi

Indication: Multiple sclerosis 

Tolebrutinib is an oral bruton tyrosine kinase inhibitor (BTK) designed to penetrate the blood-brain barrier and directly target central nervous system (CNS) inflammation. Because of how it targets the CNS, it is unlike conventional MS therapies that primarily address peripheral inflammation 

and enables direct modulation of B‑lymphocytes and disease‑associated microglia that drive smoldering neuroinflammation.

Phase 3 HERCULES trials demonstrated strong efficacy and a tolerable safety profile for patients who are being treated for non-relapsing secondary progressive MS (nrSP-MS), which means it can address the large unmet treatment gap for the MS subtype. For those with nrSP-MS, the absence of relapses does not stop the steady accumulation of disability, highlighting the need for therapies like tolebrutinib that act directly within the CNS.

Tolebrutinib could be practice changing for the management of progressive MS, particularly with the convenience of its oral administration over injectable therapies. However, nrSP-MS is a relatively narrow indication within the total MS market, and tolebrutinib’s opportunity in this subtype could be impacted by later competition from other BTK inhibitors.

BGB-16673

Manufacturer: BeOne Medicines

Indication: Chronic lymphocytic leukemia/small lymphocytic lymphoma

BGB-16673 is an oral protein degrader targeted to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is designed to promote the degradation of both wild-type and mutant forms of bruton tyrosine kinase (BTK). 

Clarivate anticipates BGB-16673 gaining approval first in the third- and later-line settings then expanding into the second-line setting based on results of global Phase 3 trials. Currently, there are limited treatment options available for double- and triple-refractory CLL/ SLL, which represents a key area of unmet need.

Early clinical data for BGB-16673 support its strong preclinical profile and has the potential to be a paradigm-changing treatment for B-cell malignancies, as it differs from traditional BTK inhibitors by inducing degradation rather than simply inhibiting activity of the BTK protein.

As it progresses toward potential blockbuster status, comparisons with noncovalent BTK inhibitors will be crucial for BGB 16673 to become established in earlier lines of treatment for relapsed or refractory disease and access larger and more lucrative patient populations.

Mezigdomide 

Manufacturer: Bristol Myers Squibb

Indication: Multiple myeloma 

Mezigdomide is an oral CELMoD therapy to treat relapsed or refractory multiple myeloma. It is designed to degrade two key transcription factors in hematopoietic cell development and differentiation — Ikaros and Aiolos — resulting in both anti-myeloma and immune-stimulatory actions.

It is currently being evaluated in two global Phase 3 trials in combination with other established therapies in patients with advanced disease and has the potential to offer new hope for patients who had previously been treated with immunomodulatory drugs.

Mezigdomide’s upcoming launch is part of the pharma company’s new multiple myeloma treatment strategy: While its other investigational multiple myeloma treatment — iberdomide — is being positioned as a more tolerable replacement for BMS’ REVLIMID in earlier-line myeloma and post-transplant maintenance, mezigdomide is aimed at being more potent replacement for IMNOVID/POMALYST in later-line, harder-to-treat patient segments. Results from the Phase 1/2 trials provide evidence for this and contributed to mezigdomide’s advancement to pivotal Phase 3 trials, according to Clarivate’s report.

However, the later-line multiple myeloma market is increasingly competitive, especially given the entry of novel modalities. 

Gedatolisib

Manufacturer: Celcuity

Indication: Breast cancer 

Gedatolisib is an intravenously administered pan-phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin (mTOR) inhibitor to treat hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. The inhibitor could address resistance mechanisms to standard endocrine therapies in HR-positive/HER2negative breast cancer due to its ability to target all four class I PI3K isoforms and mTOR.

Phase 3 trial results for gedatolisib demonstrated potentially “practice changing" effects on outcomes. Positive top-line results for the PIK3CA wild-type cohort in the pivotal Phase 3 VIKTORIA-1 trial served as the basis in its initiation of a rolling NDA submission for HR-positive/HER2-negative advanced breast cancer under the FDA’s Real-Time Oncology Review program. That trial helped establish new milestones in the history of drug development for HR-positive/HER2 negative advanced breast cancer, with unprecedented reductions in risk of disease progression or death and median progression-free survival.

However, the launch and label expansion of multiple agents in the same treatment setting are expected to result in intense competition between agents in key treatable populations, which could limit the potential of individual therapies like gedatolisib. 

INLEXZO (TAR-200)

Manufacturer: Johnson & Johnson

Indication: Bladder cancer

INLEXZO is an intravesical drug delivery system designed to address the unmet medical need for effective, less-invasive, bladder-preserving therapies in patients with high-risk non-muscle invasive bladder cancer (HR-NMIBC). It is engineered to provide continuous, local release of a cytotoxic therapy directly into the bladder. 

The system administers gemcitabine every three weeks for up to six months — followed by once every 12 weeks for up to 18 months — to treat Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with carcinoma in situ (CIS) with or without papillary tumors. The drug received FDA approval based on results from the pivotal Phase 2b SunRISe-1 trial, which showed a complete response (CR) rate of 82.4% for this patient population, with 51% of these patients maintaining CR for at least one year.

Clinical trial results for INLEXZO have demonstrated its efficacy as monotherapy, and its combination with other investigational drugs is also being evaluated, with the aim of increasing its potency and durability. 

However, to secure blockbuster status, INLEXZO will need to demonstrate durable long-term efficacy and consistent safety profile in broader real-world populations. 

Relacorilant 

Manufacturer: Corcept Therapeutics

Indication: Ovarian cancer and hypercortisolism (Cushing syndrome)

Relacorilant is an oral selective glucocorticoid receptor antagonist (SGRA) to treat platinum-resistant ovarian cancer, endogenous hypercortisolism (Cushing syndrome) and hypercortisolism associated with adrenal adenoma or hyperplasia.

With two NDAs under FDA review, relacorilant seeks to redefine treatment paradigms for patients with limited effective options by offering a novel mechanism of action through the modulation of cortisol activity — a hormone implicated in both tumor resistance and metabolic dysfunction — which sets it apart from existing treatments. Positive clinical outcomes and favorable safety profile make relicorilant well positioned to secure meaningful market share in the platinum-resistant ovarian cancer population.

Major hurdles relacorilant faces in achieving blockbuster status are primarily due to the niche nature of its target populations and the competitive landscape it must navigate, highlighted by a growing pipeline of other late-phase ADCs. However, a broad clinical program and success in additional indications such as prostate cancer — which it is also currently being evaluated for — would diversify revenue and support its blockbuster status.