Ubeslo (obicetrapib) / Tanabe Pharma, NewAmsterdam Pharma, Menarini - LARVOL DELTA

NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo (Obicetrapib Monotherapy) and Evlarco (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) (Yahoo Finance) - "The European Commission approval follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials..."

EMA approval • Cardiovascular • Dyslipidemia • Heterozygous Familial Hypercholesterolemia • Homozygous Familial Hypercholesterolemia

LIPID-LOWERING EFFECTS OF OBICETRAPIB IN PATIENTS WITH DYSLIPIDEMIA: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (CHEST 2026) - No abstract available

Retrospective data • Dyslipidemia • Metabolic Disorders

Heterogeneous biomarker responses to CETP inhibitors: a phase 3 trials systematic review and network meta-analysis (ESC 2026) - "For LDL-C, anacetrapib (MD −37.14 mg/dL; 95% CI −39.01 to −35.26) and evacetrapib (MD −37.10 mg/dL; 95% CI −38.22 to −35.98) produced the largest reductions; obicetrapib also significantly reduced LDL-C (MD −24.00 mg/dL; 95% CI −28.64 to −19.36) (Fig. CETP inhibitors produce substantial and consistent improvements in lipid biomarkers, but inflammatory responses differ across agents (CRP elevation with anacetrapib and evacetrapib), indicating class heterogeneity. Ongoing cardiovascular outcome trials are needed to determine whether these biomarker changes translate into reductions in residual ASCVD risk."

Biomarker • Heterogeneity • P3 data • Retrospective data • Review • Cardiovascular • APOB

RUBENS: A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: NewAmsterdam Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Pooled on treatment lipid lowering efficacy of the CETP inhibitor obicetrapib in phase III trials (ESC 2026) - "LDL‑C decreased by ‑55.8%, with 79.8% and 72.7% achieving <70 mg/dL and <55 mg/dL (placebo: 20.4% and 7.1%) [FIGURE 2]. Conclusions Both obicetrapib and the obicetrapib–ezetimibe fixed‑dose combination on‑treatment populations showed substantial LDL‑C reduction, with 3 out of 4 patients reaching a LDL-C goal of <55 mg/dL and 4 out of 5 patients achieving a LDL-C goal of <70 mg/dL with the obicetrapib + ezetimibe fixed dose combination."

Clinical • P3 data • Cardiovascular • Dyslipidemia • APOB

Determinants of short term Lp(a) variability in phase 3 obicetrapib trials (ESC 2026) - "Over 12 weeks in obicetrapib phase 3 studies, a meaningful subset of participants unselected for Lp(a) shifted into a range where obicetrapib has demonstrated >40% reductions in Lp(a) — 50 to <150 nmol/L — while baseline levels explained a significant proportion of the variability in concentrations. These findings suggest that if Lp(a) lowering is proven to reduce cardiovascular risk, repeated testing may be warranted to determine if individuals who otherwise would not be eligible for treatment with a targeted Lp(a) lowering agent may benefit from such lowering with obicetrapib."

P3 data • Cardiovascular

SPINOZA: Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: NewAmsterdam Pharma

New P2 trial • Alzheimer's Disease • CNS Disorders

NewAmsterdam Pharma Announces Upcoming Presentations at the European Society of Cardiology (ESC) Congress 2026 (Yahoo Finance)

Clinical data • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Comparative Biomarker Efficacy of CETP Inhibitors: A Network Meta-Analysis. (PubMed, Eur Heart J Cardiovasc Pharmacother) - No abstract available

Biomarker • Journal • Retrospective data • Dyslipidemia

Obicetrapib-ezetimibe combination therapy: a novel oral strategy for enhanced lipid lowering. (PubMed, Cardiovasc Res) - No abstract available

Journal

Upcoming Milestones and Ongoing Trials (The Manila Times) - "PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027...NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib for the prevention of early Alzheimer’s disease in 2026."

New trial • P3 data • Alzheimer's Disease • Atherosclerosis • Cardiovascular

Targeting the CTBP1-CETP axis overcomes ferroptosis resistance in non-small cell lung cancer by altering lipid accumulation. (PubMed, Clin Transl Med) - "Our study delineates a novel CTBP1-CETP-lipid droplet-MAPK signalling cascade that couples metabolic rewiring with ferroptosis evasion. These insights establish the CTBP1-CETP axis as a critical cell fate determinant, positioning pharmacological CETP inhibition (e.g., obicetrapib) as a translatable therapeutic vulnerability in lipid-dependent, ferroptosis-resistant NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • CTBP1

NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo (Obicetrapib Monotherapy) and Evlarco (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) (GlobeNewswire) - "European Commission decision expected in 2H26...The positive CHMP recommendation is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials..."

CHMP • EMA approval • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

NewAmsterdam Pharma publishes obicetrapib Alzheimer’s prevention research presentation (Bitget) - "NewAmsterdam Pharma published a research presentation on CETP inhibition for Alzheimer’s prevention, centered on its CETP inhibitor obicetrapib; In the Phase 3 BROADWAY AD biomarker substudy, 12 months of obicetrapib reduced plasma p-tau217 versus placebo, strongest in APOE4/E4 carriers; The presentation also cited favorable shifts across other Alzheimer’s-related biomarkers, supporting a rationale for prevention trials in at-risk APOE4 populations."

P3 data • Alzheimer's Disease

Efficacy and safety of obicetrapib in patients at high cardiovascular risk: a systematic review, meta-analysis, and meta-regression. (PubMed, Ann Med Surg (Lond)) - "Obicetrapib produces substantial, consistent improvements in atherogenic and anti-atherogenic lipid fractions without increasing adverse events. It holds promise as an adjunctive therapy for high-risk patients with residual dyslipidemia despite optimal statin therapy, pending confirmation from cardiovascular outcome trials."

Journal • Retrospective data • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • APOB

Cambrex…proudly announces that Snapdragon Chemistry, a Cambrex company, together with NewAmsterdam Pharma, has received the American Chemical Society's 2026 Green Chemistry Challenge Award for the Greener Synthetic Pathway in the Synthesis of Pharmaceuticals (PRNewswire) - "The award recognizes the companies' successful development of a sustainable organocatalytic process to manufacture the chiral tetrahydroquinoline core for the synthesis of obicetrapib, a late-stage investigational therapy for dyslipidemia....Compared with the previous manufacturing route, the organocatalytic process significantly improved overall efficiency and sustainability, delivering substantial gains in yield, reducing process mass intensity by approximately 80%, eliminating aqueous waste generation, shortening manufacturing cycle time by approximately 70% and lowering manufacturing costs by approximately 50%."

Commercial • Dyslipidemia

Lipid-Lowering Efficacy and Safety of Obicetrapib Alone and as an Add on Therapy: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Cardiol Rev) - "As an add-on therapy to ezetimibe, obicetrapib yielded greater reduction in low-density lipoprotein [MD, -51.99 (95% CI, -61.61 to -42.37), P < 0.001] and non-HDL [MD, -50.32 (-55.42 to -45.21), P < 0.001]. No significant effects were observed when combined with statins."

Journal • Retrospective data • Dyslipidemia • APOA1 • APOB • APOE

Obicetrapib safety analysis: Pooled phase 3 clinical trial experience. (PubMed, Am J Prev Cardiol) - "Obicetrapib demonstrated a favorable safety profile over 12 months, with AE rates comparable to placebo. These findings extend our understanding of the safety and tolerability of obicetrapib."

Journal • P3 data • Age-related Macular Degeneration • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Hypertension • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders

NewAmsterdam Pharma Company…announced that it will present data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for the prevention of early Alzheimer’s disease, at the Alzheimer's Association International Conference (AAIC) 2026 (GlobeNewswire)

Clinical data • Alzheimer's Disease

CETP Inhibition For Alzheimer's Prevention: Obicetrapib's Multi‑Pathway Effects On Lipid‑Mediated Pathophysiology (AAIC 2026) - No abstract available

Alzheimer's Disease • CNS Disorders

Cholesteryl ester transfer protein inhibition with obicetrapib is associated with attenuated decline in kidney function in patients at high cardiovascular risk: Post hoc pooled results from the BROADWAY and BROOKLYN trials. (PubMed, Am J Prev Cardiol) - "Annualized percent change in UACR was not significantly different between groups. In patients at high cardiovascular risk, CETP inhibition with obicetrapib may attenuate kidney function decline, potentially through its HDL-raising effects."

Journal • Retrospective data • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • Nephrology • Renal Disease • APOA1

Obicetrapib and renal function: A welcome signal, but not yet a kidney story. (PubMed, Am J Prev Cardiol) - No abstract available

Journal

CETP Inhibitors: Back With a New Target. (PubMed, Circ Res) - "Obicetrapib is a highly selective CETP inhibitor with evidence of favorable effects on atherogenic lipids and lipoproteins, glycemic control, and biomarkers of beta-amyloid pathology in preclinical Alzheimer disease. The ongoing potential for CETP inhibition as an effective tool in the prevention clinic and other emerging applications will be reviewed."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Diabetes • Metabolic Disorders

NewAmsterdam Pharma Announces Upcoming Presentations at the National Lipid Association (NLA) 2026 Scientific Sessions (GlobeNewswire)

Clinical data • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia

MEDICI: Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days (clinicaltrials.gov) - P3 | N=426 | Recruiting | Sponsor: A. Menarini International Licensing S.A.

New P3 trial • Cardiovascular • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia