{"id":585882,"date":"2026-07-08T15:00:49","date_gmt":"2026-07-08T15:00:49","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=585882"},"modified":"2026-07-08T15:00:49","modified_gmt":"2026-07-08T15:00:49","slug":"tracking-the-mid-year-momentum-of-the-2026-drugs-to-watch","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/blog\/tracking-the-mid-year-momentum-of-the-2026-drugs-to-watch\/","title":{"rendered":"Tracking the mid-year momentum of the 2026 Drugs to Watch"},"content":{"rendered":"

At the midpoint of 2026, the majority of the therapies highlighted in our 2026 Drugs to Watch report<\/a> have reached significant milestones. The first half of the year has been characterized by rapid regulatory progress, with some therapies securing approvals ahead of their projected timelines while others have seen regulatory setbacks that slowed progress. Alongside these regulatory decisions, critical phase 3 clinical trial readouts and market entries are actively shaping the therapeutic landscape. This mid-year update tracks the progress of these treatments, summarizing their latest clinical data and regulatory status as they transition from development pipelines to clinical practice.<\/p>\n

Cenrifki (tolebrutinib) for multiple sclerosis \u2014 Sanofi<\/h3>\n

In December 2025, Sanofi received a Complete Response Letter (CRL) for tolebrutinib<\/a> as treatment for non-relapsing secondary progressive multiple sclerosis (nrSP-MS), following the earlier CRL<\/a> for treatment for primary progressive MS (PP-MS).<\/p>\n

In April 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) adopted a positive opinion recommending the approval of Cenrifki<\/a> in the E.U. for SP-MS without relapses in the last two years. The positive opinion was based on data from the phase 3 HERCULES, GEMINI 1 and GEMINI 2 studies. Approval in the E.U. followed in June 2026, making it the first disability-targeting therapy for nrSP-MS available in the region. Cenrifki was also approved in Australia in May 2026, and it is expected to become commercially available in Germany in 2026. The drug remains under regulatory review in other jurisdictions worldwide.<\/p>\n

Read more about <\/em>Cenrifki<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

Exdensur (depemokimab) for asthma and other IL-5-mediated diseases \u2014 GSK<\/h3>\n

Exdensur has been approved in multiple markets since the publication of Drugs to Watch. On January 6, 2026, GSK reported approval by the Ministry of Health & Welfare in Japan<\/a> for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).<\/p>\n

On February 17, 2026, the European Commission (EC) approved Exdensur<\/a> for two indications: (1) add-on maintenance treatment for severe asthma with type 2 inflammation characterized by blood eosinophil count in adults and adolescents \u226512 years and (2) add-on therapy with intranasal corticosteroids to treat adult patients with severe CRSwNP.<\/p>\n

The approvals in Japan and the E.U. were based on results from the phase 3 SWIFT and ANCHOR trials. This made it the first ultra-long-acting biologic in Japan for the two conditions and in the E.U. for respiratory diseases.<\/p>\n

On March 30, 2026, Exdensur was approved by Mainland China\u2019s National Medical Products Administration (NMPA)<\/a> as add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. The approval was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials. Exdensur is now the first and only ultra-long-acting biologic in Mainland China for the treatment of severe asthma with an eosinophilic phenotype. Exdensur is also being reviewed by the NMPA as add-on therapy with intranasal corticosteroids to treat severe CRSwNP in adults for whom adequate disease control is not provided by therapy with systemic corticosteroids and\/or surgery.<\/p>\n

In May 2026, GSK presented new data<\/a> on Exdensur at American Thoracic Society (ATS) 2026, highlighting sustained efficacy and safety from the phase 3 SWIFT-1\/-2 and AGILE extension studies for patients with severe asthma and type 2 inflammation. The results demonstrated durable outcomes for up to two years as well as subgroup and patient preference analyses supporting the benefit of twice-yearly dosing. These findings reinforced its potential as a long-acting biologic option with a differentiated dosing profile in the severe asthma treatment landscape.<\/p>\n

Read more about <\/em>Exdensur<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

Gedatolisib for HR-positive\/HER2-negative metastatic breast cancer \u2014 Celcuity<\/h3>\n

On January 20, 2026, the FDA accepted the NDA<\/a> for gedatolisib in HR-positive\/HER2-negative, PIK3CA<\/em> wild-type advanced breast cancer based on results from the cohort with PIK3CA<\/em> wild-type advanced breast cancer in the phase 3 VIKTORIA-1 trial. The FDA granted Priority Review and assigned a PDUFA date of July 17, 2026.<\/p>\n

Celcuity presented positive topline results<\/a> from the PIK3CA<\/em> mutant cohort of the phase 3 VIKTORIA-1 trial in May 2026. For patients with HR-positive\/HER2-negative PIK3CA<\/em> mutant locally advanced or metastatic breast cancer following progression on\/after treatment with a CDK4\/6 inhibitor and an aromatase inhibitor, statistically significant and clinically meaningful improvement in progression-free survival (PFS) occurred with gedatolisib combined with fulvestrant and palbociclib compared with alpelisib (PI3K\u03b1 inhibitor) and fulvestrant. These data were presented at ASCO\u00ae<\/sup><\/strong> 2026 and will be submitted as an sNDA to the FDA as well as to other regulatory authorities.<\/p>\n

Results from study 2 of the phase 3 VIKTORIA-1 trial<\/a> were also reported by Celcuity in June 2026 and presented at ASCO 2026. For the PIK3CA<\/em>-mutant cohort, a statistically significant and clinically meaningful improvement in median PFS occurred with gedatolisib combined with fulvestrant and palbociclib (triplet; 11.1 months) or only fulvestrant (doublet; 11.3 months) compared with alpelisib combined with fulvestrant (5.6 months). Objective response rates (ORRs) were 48.9%, 35.7% and 26.0%, respectively. Safety data were similar to that reported in study 1 with the PIK3CA<\/em> wild-type patient cohort: lower levels of hyperglycemia and higher levels of stomatitis compared with the control arm.<\/p>\n

In May 2026, Celcuity also announced an expansion<\/a> of the phase 3 VIKTORIA-2 trial to include endocrine sensitive patients. The VIKTORIA-2 trial included first-line metastatic HR-positive\/HER2-negative patients with an early relapse following adjuvant endocrine therapy, an endocrine-resistant population with an unmet need. Expanding to include endocrine-sensitive patients provides a broader first-line population. Although this increases gedatolisib\u2019s commercial potential, gedatolisib-based regimens will need to show benefit over entrenched first-line SOC (CDK4\/6 inhibitor + endocrine therapy), Clarivate analysis indicates. This sets a high benchmark in endocrine-sensitive disease, in addition to safety and cost implications.<\/p>\n

Read more about <\/em>gedatolisib<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

ICOTYDE\u2122 (icotrokinra) for plaque psoriasis \u2014 Johnson & Johnson<\/h3>\n

On March 18, 2026, ICOTYDE\u2122 (icotrokinra) was approved by the FDA<\/a> as the first interleukin-23 (IL-23)-targeted oral peptide to treat moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. Approval was based on evidence across four phase 3 studies in the ICONIC clinical development program.<\/p>\n

Later that month, Johnson & Johnson reported 52-week data from the phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies<\/a>, which showed high rates of complete skin clearance. In the ICONIC-ADVANCE 1 and 2 studies, the rates of completely clear skin (PASI 100) increased from 41% to 49% and 33% to 48% from week 24 to week 52, respectively, in participants with moderate-to-severe plaque psoriasis in the treatment arm, with no new safety signals. In ICONIC-LEAD, nearly 60% of adolescents achieved completely clear skin (57% PASI 100, 61% IGA 0) at week 52 with ICOTYDE, and 86% achieved PASI 90 response at one year, with 92% maintaining that response from week 24 to week 52. Throughout the 52 weeks, no increase in AE incidence was observed.<\/p>\n

Read more about <\/em>ICOTYDE<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

INLEXZO\u2122 for bladder cancer \u2014 Johnson & Johnson<\/h3>\n

A permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9183) was assigned<\/a> by the Centers for Medicare & Medicaid Services (CMS) for INLEXZO, effective April 1, 2026. The J-code provides a standardized billing and reimbursement pathway in the U.S. and could support broader patient access and uptake.<\/p>\n

Read more about <\/em>INLEXZO<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

Lifyorli\u2122 (relacorilant) for ovarian cancer \u2014 Corcept Therapeutics Inc<\/h3>\n

In December 2025, Corcept Therapeutics Inc received a CRL<\/a> for the NDA relacorilant as a treatment for hypertension secondary to hypercortisolism (Cushing disease). The FDA concluded it required additional evidence of effectiveness<\/a> for the benefit-risk assessment.<\/p>\n

Then, in January 2026, the company announced that the overall survival primary endpoint had been met<\/a> in the pivotal phase 3 ROSELLA trial with patients with platinum-resistant ovarian cancer. Lifyorli plus nab-paclitaxel resulted in a 35% reduction in the risk of death, compared with nab-paclitaxel alone. The trial also met both dual primary endpoints: PFS: 30% reduction in disease progression risk; overall survival: 16 months vs 11.9 months. The combination was also well-tolerated, did not increase the safety burden and did not require biomarker selection.<\/p>\n

In March 2026, less than three months after the CRL for Cushing disease, the FDA approved Lifyorli (relacorilant)<\/a> plus nab-paclitaxel to treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. This makes Lifyorli the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). Approval was based on positive outcomes from the pivotal ROSELLA trial.<\/p>\n

Read more about <\/em>Lifyorli<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

Mezigdomide for multiple myeloma \u2014 Bristol Myers Squibb<\/h3>\n

In March 2026, positive interim results<\/a> were reported from the phase 3 SUCCESSOR-2 study, which is evaluating mezigdomide in combination with carfilzomib and dexamethasone. The interim results showed statistically significant and clinically meaningful improvements in PFS versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma.<\/p>\n

Late-breaking results from the same study<\/a> were also presented at ASCO 2026 a couple of months later. Statistically significant and clinically meaningful improvements in PFS (18.0 months vs. 8.3 months) represented a 52% reduction in the risk of disease progression or death compared with carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma (95% CI 0.36\u20130.63). Higher ORR (80.2% vs 53.4%) and complete response or better (26.7% vs 8.9%) were also observed.<\/p>\n

Read more about <\/em>mezigdomide<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

Orforglipron for obesity (Foundayo\u2122) and type 2 diabetes \u2014 Eli Lilly and Co<\/h3>\n

In December 2025, Eli Lilly and Co announced topline results<\/a> from one year of the ATTAIN-MAINTAIN trial. Foundayo helped people maintain weight loss after switching from injectable incretins to the oral GLP-1 therapy in the first-of-its-kind trial that involved participants from SURMOUNT-5. When compared with placebo for weight maintenance, Foundayo provided superior percent maintenance of body weight reduction.<\/p>\n

On April 1, 2026, the FDA approved Foundayo (orforglipron)<\/a> for adults with obesity or overweight with weight-related medical problems. This made Foundayo the first FDA-approved non-peptide oral GLP-1 RA for obesity\/overweight and Eli Lilly and Co\u2019s second obesity drug approved by the FDA. Approval was based on positive data from the ATTAIN clinical trial program. The company said it would make Foundayo available first via LillyDirect\u00ae<\/em>, with shipping expected to begin April 6, after which it became available via U.S. retail pharmacies and telehealth providers.<\/p>\n

A couple of weeks later, Eli Lilly and Co announced positive topline results from the phase 3 ACHIEVE-4 trial<\/a> of orforglipron for type 2 diabetes. The longest phase 3 study of orforglipron to date, the ACHIEVE-4 trial enrolled more than 2,700 adults with type 2 diabetes and obesity or overweight with increased cardiovascular risk. The primary objective of non-inferiority vs insulin glargine was met, with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events as well as 57% lower risk of all-cause death. The company plans to use these data to submit to the FDA for type 2 diabetes under the Commissioner\u2019s National Priority Review Voucher by the end of Q2 2026.<\/p>\n

Read more about <\/em>orforglipron (Foundayo)<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

Retatrutide for obesity and type 2 diabetes \u2014 Eli Lilly and Co<\/h3>\n

In March 2026, Eli Lilly and Co announced positive topline results for type 2 diabetes<\/a> from the phase 3 TRANSCEND-T2D-1 trial. Retatrutide met the primary and all key secondary endpoints at 40 weeks in adults diagnosed with type 2 diabetes with inadequate glycemic control with diet and exercise alone and a mean duration of diabetes of 2.5 years. According to the treatment estimand results, retatrutide lowered HbA1c by an average of 1.7% to 1.9% across doses (vs 0.8% with placebo). Up to 15.3% weight loss was achieved (vs 2.6% with placebo).<\/p>\n

A couple of months later, in May 2026, Eli Lilly and Co reported up to 28.3% weight loss<\/a> in the pivotal phase 3 TRIUMPH-1 trial. Retatrutide met the primary and key secondary endpoints for obesity at 80 weeks across all retatrutide doses (4 mg, 9 mg and 12 mg), delivering clinically meaningful weight loss. According to the treatment estimand results, retatrutide resulted in 17.6% (4 mg), 23.7% (9 mg) and 25.0% (12 mg) weight loss across the treatment arms (vs 3.9% with placebo). Up to 27% of participants in the 12-mg dose group achieved \u226535% weight loss. Significant improvements were also observed from baseline in waist circumference, non-HDL cholesterol, triglycerides, systolic blood pressure and hsCRP. The discontinuation rate due to adverse events was 4.1% (4 mg), 6.9% (9 mg) and 11.3% (12 mg) (vs 4.9% with placebo).<\/p>\n

Read more about <\/em>retatrutide<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

VOYXACT\u00ae (sibeprenlimab) for immunoglobulin A nephropathy (IgAN) \u2014 Otsuka Pharmaceutical Co Ltd<\/h3>\n

In June 2026, Otsuka Pharmaceutical Co Ltd reported positive interim data from the phase 3 VISIONARY trial<\/a>. Presented at the at the European Renal Association (ERA) Congress 2026, the results showed preserved kidney function over 12 months compared with placebo in adults with primary IgAN at risk for disease progression: mean change in eGFR from baseline of +0.7 mL\/min\/1.73 m2<\/sup> with VOYXACT vs -4.8 mL\/min\/1.73 m2<\/sup> with placebo, a treatment effect of 5.5 mL\/min\/1.73 m\u00b2. VOYXACT\u2019s overall safety profile was similar to that of placebo. Full data are expected at a future conference.<\/p>\n

The following week, the company announced that sibeprenlimab had been approved in Mainland China<\/a> under the brand name Izaike\u00ae. The NMPA approved Izaike to reduce proteinuria in adults with primary IgAN at risk of disease progression. The approval was based on results from the phase 3 VISIONARY study, which included 102 participants from Mainland China. In the Chinese subgroup, sibeprenlimab treatment resulted in a 61.9% decrease in the 24-hour urine protein-to-creatinine ratio (UPCR) at 9 months compared with placebo. A 51.2% reduction in 24-hour UPCR vs placebo at 9 months was reported for the overall study population.<\/p>\n

Read more about <\/em>VOYXACT<\/em><\/a> in the 2026 Drugs to Watch report.<\/em><\/p>\n

How the H1 2026 milestones shape the future market<\/h3>\n

For the 2026 Drugs to Watch, the regulatory approvals and strong phase 3 data readouts seen so far this year underscore both the clinical demand and the regulatory priority assigned to these pipelines. As we enter the second half of the year, this momentum, driven by upcoming decisions and ongoing clinical trials, will continue to clarify how these therapies fit into the global healthcare landscape.<\/p>\n

Find the full Drugs to Watch 2026 report here: Drugs to Watch 2026 – Top Emerging Therapies | Clarivate.<\/a><\/em><\/strong><\/p>\n

To learn more about how Cortellis Regulatory Intelligence helps life science companies confidently navigate the global regulatory landscape, please visit us here: <\/em>Cortellis Regulatory Intelligence AI-Powered Software<\/em><\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

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