The mid-year update to 2026 Drugs to Watch shows how quickly the pharmaceutical pipeline can change. By July, several therapies had already secured regulatory approvals, while others produced important Phase 3 results or encountered setbacks. Key developments included EU approval for Sanofi’s Cenrifki, FDA approval of Johnson & Johnson’s ICOTYDE and Eli Lilly’s oral GLP-1 drug Foundayo, alongside major late-stage data for retatrutide and gedatolisib.
Regulatory momentum accelerates in 2026
At the start of the year, Clarivate identified 11 therapies with the potential to transform treatment paradigms or achieve blockbuster status within the next five years. By the midpoint of 2026, most of those medicines had reached a significant regulatory, clinical or commercial milestone.
The first half of the year was marked by a mixture of rapid approvals, important Phase 3 trial results and regulatory obstacles. This uneven progress illustrates a central feature of drug development: promising clinical data do not always translate into immediate market access, while some therapies can advance faster than initially expected.
Multiple sclerosis sees a breakthrough
One of the most significant developments involved Cenrifki (tolebrutinib), developed by Sanofi.
After receiving Complete Response Letters from the FDA in late 2025 for different multiple sclerosis indications, the therapy moved forward in Europe. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion in April, followed by EU approval in June for secondary progressive multiple sclerosis without relapses during the previous two years.
According to Clarivate, the approval made Cenrifki the first disability-targeting therapy available in the EU for this form of non-relapsing secondary progressive multiple sclerosis. The drug had also been approved in Australia in May and remained under review in other markets.
Long-acting asthma treatment expands
Exdensur (depemokimab) from GSK also made significant regulatory progress.
The therapy received approval in Japan in January for severe asthma and chronic rhinosinusitis with nasal polyps, followed by European Commission approval in February for severe asthma with type 2 inflammation and for certain patients with severe chronic rhinosinusitis with nasal polyps. China later approved the medicine for eosinophilic severe asthma.
The approvals were supported by Phase 3 clinical data and positioned Exdensur as an ultra-long-acting biologic with twice-yearly dosing potential, an approach that could reduce treatment frequency for eligible patients.
Oral psoriasis therapy reaches the market
In March, Johnson & Johnson received FDA approval for ICOTYDE (icotrokinra) for moderate-to-severe plaque psoriasis.
Clarivate described the treatment as the first FDA-approved oral peptide targeting interleukin-23 for this patient population. The approval was supported by four Phase 3 studies in the ICONIC development program.
Subsequent 52-week results reported by the company showed continued skin-clearance responses in clinical trial participants, including adolescent patients. However, treatment decisions still depend on individual disease severity, safety considerations and comparisons with existing therapies.
Oral GLP-1 therapy moves ahead
The metabolic disease market also saw major progress.
Eli Lilly and Company received FDA approval on April 1 for Foundayo (orforglipron) for adults with obesity or overweight accompanied by weight-related medical problems, according to Clarivate’s mid-year update.
The approval made Foundayo the first FDA-approved non-peptide oral GLP-1 receptor agonist for obesity or overweight. The drug’s development program also continued in type 2 diabetes, with additional Phase 3 data reported during the first half of the year.
The development is particularly significant because oral therapies could expand options for patients who prefer not to use injectable treatments. Whether this translates into broader uptake will depend on effectiveness, safety, pricing, reimbursement and real-world adherence.
Retatrutide posts major Phase 3 results
Eli Lilly’s retatrutide remained one of the most closely watched experimental medicines in obesity and type 2 diabetes.
In March, the company reported positive Phase 3 results in type 2 diabetes, followed in May by pivotal obesity data from the TRIUMPH-1 trial. Clarivate reported substantial reductions in body weight across different dose groups and significant improvements in glycemic control in the diabetes program.
Despite the strong results, retatrutide remained part of the development pipeline in the mid-year update rather than being presented as an approved therapy. Further regulatory review and additional evidence will determine its eventual place in clinical practice.
Breast cancer data reshape expectations
The oncology pipeline also produced significant results for gedatolisib, developed by Celcuity.
The FDA accepted the company’s New Drug Application in January for a subgroup of patients with HR-positive, HER2-negative advanced breast cancer and granted Priority Review. Meanwhile, additional Phase 3 VIKTORIA-1 results presented in 2026 showed improvements in progression-free survival in patients with PIK3CA-mutant disease.
Clarivate noted that the findings could expand the therapy’s commercial potential, but future positioning will depend on how gedatolisib-based regimens compare with established standards of care, as well as their safety and cost profiles.
From pipeline to clinical practice
The first half of 2026 demonstrates that the path from clinical development to patient care is rarely straightforward.
Some therapies highlighted in 2026 Drugs to Watch advanced through approvals faster than anticipated. Others remained under regulatory review or faced setbacks. At the same time, Phase 3 trial results continued to influence expectations about which medicines could eventually reshape treatment across neurology, immunology, oncology and metabolic disease.
As the second half of the year progresses, further regulatory decisions and clinical trial readouts are expected to determine which of these medicines successfully transition from promising pipeline candidates into established treatment options.
Why It Matters
The mid-year progress of 2026 Drugs to Watch highlights how rapidly the pharmaceutical landscape can evolve. Regulatory approvals are bringing new treatments to patients, while Phase 3 data continue to reshape expectations for obesity, cancer, multiple sclerosis and immune-mediated diseases. At the same time, setbacks underline that promising clinical results do not guarantee approval or commercial success.
Frequently Asked Questions
What is the 2026 Drugs to Watch report?
The 2026 Drugs to Watch report is an annual analysis by Clarivate identifying therapies considered likely to reach important milestones, reshape treatment approaches or potentially achieve blockbuster status within five years. The 2026 edition identified 11 key therapies.
Which drugs made major progress in the first half of 2026?
Among the notable developments were EU approval of Cenrifki, international approvals for Exdensur, FDA approval of ICOTYDE and Foundayo, and major Phase 3 results for retatrutide and gedatolisib.
Is retatrutide approved for obesity?
No approval was reported in Clarivate’s July 2026 mid-year update. The medicine had produced positive Phase 3 results, but remained in clinical development and subject to future regulatory review.
Why are mid-year drug pipeline updates important?
They show how clinical trial results, regulatory decisions and commercial launches can rapidly change the outlook for new medicines. A therapy may move closer to routine clinical use, face additional regulatory requirements or produce new evidence that changes its expected role in treatment.
Sources: Clarivate
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