Tepezza (teprotumumab-trbw) / Genmab, Roche, Amgen - LARVOL DELTA

Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Shanghai Changzheng Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease (clinicaltrials.gov) - P4 | N=92 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P4 trial • Ophthalmology • Thyroid Eye Disease

Longitudinal Glycemic Outcomes in Patients With Thyroid Eye Disease Treated With Teprotumumab. (PubMed, Ophthalmic Plast Reconstr Surg) - "Teprotumumab may be associated with worsening of glycemic control, with the most pronounced and persistent effects in patients with preexisting glycemic disturbances. The varied timing of peak HbA1c and ongoing need for medical treatment highlight the importance of systematic glycemic risk assessment and routine HbA1c monitoring throughout and after treatment to guide clinical management."

Journal • Metabolic Disorders • Ophthalmology • Thyroid Eye Disease

Comparison of the 2021 EUGOGO guidelines and the 2022 ATA/ETA consensus statement for the management of Graves' orbitopathy. (PubMed, Eur Thyroid J) - "However, also in the ATA/ETA consensus statement IVGC are the preferred treatment when the goal is GO inactivation and resolution of inflammation, and among the preferred treatments (in combination with orbital radiotherapy) when the goals are inactivation and correction of eye dysmotility. Recent developments to be considered in future revisions of the guidelines/consensus statement include the possible use of biologicals (teprotumumab, tocilizumab) for dysthyroid optic neuropathy, treatment of longstanding, inactive GO with teprotumumab, reconsideration of the cautious use of radioactive iodine in patients with moderate-to-severe and active GO concomitantly treated with IVGC (with/without orbital radiotherapy), use of statins as an adjunct therapy."

Journal • Inflammation • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Thyroid Eye Disease

Preclinical pharmacology, pharmacokinetics, and pharmacodynamics of veligrotug, a full antagonist antibody to the IGF-1 receptor in development for thyroid eye disease. (PubMed, MAbs) - "Binding epitope and antagonist properties were compared to teprotumumab (Tepezza®), a marketed anti-IGF-1R antibody. Veligrotug's pharmacologic, pharmacokinetic, and pharmacodynamic characteristics make it a good candidate for clinical development. Indeed, efficacy data at week 15 from two Phase 3 pivotal studies of veligrotug, THRIVE and THRIVE-2, showed statistically significant improvements in TED symptoms based on primary and secondary outcomes."

Journal • PK/PD data • Preclinical • Endocrine Disorders • Grave’s Disease • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • IGF1 • IR

Advancing the Therapeutic Frontier in Thyroid Eye Disease. (PubMed, touchREV Endocrinol) - "However, newer therapies, notably teprotumumab (a monoclonal antibody against the insulin-like growth factor I receptor), offer targeted immunomodulation with promising outcomes in reducing proptosis and improving symptoms. The future of TED treatment lies in further research on biologics, personalized approaches and continued multidisciplinary collaboration to optimize patient care."

Journal • Endocrine Disorders • Immunology • Inflammation • Ocular Inflammation • Oncology • Ophthalmology • Thyroid Eye Disease

Number of Inquiries for a Second Course of Teprotumumab in the US Over Four Years (ISPOR-EU 2025) - "This data is derived from the largest teprotumumab cohort available to date. This study examines only the proportion of patients for whom a second course of treatment was requested. Results indicated that although some patients with TED required further treatment, the number of inquiries for a second course of teprotumumab was limited to 10.8% among patients completing 8 infusions at first course without disruption over 4 years."

Immunology • Novel Coronavirus Disease • Ophthalmology • Thyroid Eye Disease

Transformation of Thyroid Eye Disease Phenotype Following Teprotumumab Treatment. (PubMed, Ophthalmic Plast Reconstr Surg) - "Following completion of treatment, a reactivation was associated with progression to severe type II phenotype, with marked extraocular muscle enlargement, bilateral proptosis, and nonsteroid-responsive compressive optic neuropathy requiring orbital decompression. This case raises important questions regarding the potential influence of Insulin-like growth factor 1 (IGF-1) suppression on the phenotype of thyroid eye disease."

Journal • Endocrine Disorders • Grave’s Disease • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Thyroid Eye Disease • IGF1

Teprotumumab treatment for dysthyroid optic neuropathy. (PubMed, Orbit) - "Despite proptosis regression, nearly all patients remained CON-free at long-term follow-up. These results suggest that teprotumumab may be an effective treatment for dysthyroid optic neuropathy, especially for patients with mild CON."

Journal • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Thyroid Eye Disease

Teprotumumab for thyroid eye disease: A reality check. (PubMed, Cleve Clin J Med) - No abstract available

Journal • Ophthalmology • Thyroid Eye Disease

Efficacy of Teprotumumab in Graves Disease with Pretibial Myxedema (ChiCTR) - P4 | N=20 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P4 trial • Endocrine Disorders • Grave’s Disease

Anti-IGF-1R antisense oligonucleotide CT102: A promising therapeutic agent for graves' ophthalmopathy. (PubMed, J Pharmacol Exp Ther) - "Furthermore, CT102 demonstrates superior modulation of GO-associated biomarkers relative to 2 positive controls: teprotumumab, the only anti-IGF-1R antibody approved by the US Food and Drug Administration, and miR-143, an RNA therapeutic targeting IGF-1R. To our knowledge, this study provides, for the first time, a rationale for clinical trials of CT102 in patients with GO and highlights the potential of anti-IGF-1R antisense oligonucleotides as a therapeutic strategy for GO. SIGNIFICANCE STATEMENT: To our knowledge, this study is the first to describe the therapeutic potential of anti- insulin-like growth factor-1 receptor antisense oligonucleotides in Graves' ophthalmopathy (GO), providing the rationale for future clinical trials in patients with GO and highlighting the potential of anti-insulin-like growth factor-1 receptor antisense oligonucleotide as a therapeutic strategy for GO."

Journal • Immunology • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • MIR143

Effectiveness and Safety of Teprotumumab in patients with thyroid eye disease (ChiCTR) - P=N/A | N=42 | Not yet recruiting | Sponsor: Tianjin Medical University Eye Hospital; Tianjin Medical University Eye Hospital

New trial • Ophthalmology • Thyroid Eye Disease

Differential change in extraocular muscle volume after teprotumumab for thyroid eye disease. (PubMed, Orbit) - "Teprotumumab significantly reduces EOM volumes, CAS, and proptosis in TED. Weak correlations with clinical outcomes suggest that additional factors, such as orbital fat, influence treatment response."

Journal • Ophthalmology • Thyroid Eye Disease

A Nationwide Survey by the Korean Society of Ophthalmic Plastic and Reconstructive Surgery (KSOPRS) on the Management of Thyroid Eye Disease in Korea. (PubMed, Korean J Ophthalmol) - "Korean oculoplastic surgeons generally follow international TED guidelines, favoring IV GC and conventional therapies over biologics due to access and cost barriers. As biologics like teprotumumab become more accessible, region-specific guidelines integrating global evidence and local healthcare constraints will be critical for optimized patient care."

Journal • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Thyroid Eye Disease

IGF-1R Inhibitor IBI311 for the Treatment of Active Thyroid Eye Disease in Chinese Patients: The RESTORE-1 Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P2/3 | "To assess efficacy and safety of IBI311, an IGF-1R inhibitor with an identical amino acid sequence to teprotumumab but a different dosage form, in Chinese patients with active TED. The results suggest that IBI311 represents a viable treatment option for Chinese patients with active TED. ClinicalTrials.gov Identifier: NCT05795621."

Clinical • Journal • Diabetes • Ophthalmology • Thyroid Eye Disease

Hearing Loss in Hyperthyroid Patients Treated with Tepezza (AAO-HNSF 2025) - "Tepezza use in hyperthyroid patients is associated with a higher risk of sensorineural and unspecified hearing loss. These findings underscore the importance of vigilant monitoring when prescribing this medication for GED."

Clinical • Endocrine Disorders • Ophthalmology • Otorhinolaryngology • Thyroid Eye Disease

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=89 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Amgen | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Thyroid Eye Disease Research From 2010 to 2024: An Analysis of Social Media Impact Versus Traditional Citation Metrics. (PubMed, Ophthalmic Plast Reconstr Surg) - "Traditional citation metrics and social media impact measures capture different aspects of research influence in thyroid eye disease literature. The emergence of high-impact therapeutic studies, particularly regarding teprotumumab, demonstrates how breakthrough research can achieve substantial impact across both traditional and alternative metrics. Given the increasing role of social media in research dissemination and patient education, clinicians should consider both traditional and alternative metrics when evaluating research impact and should be prepared to discuss studies that achieve high social media engagement with patients."

Journal • Ophthalmology • Thyroid Eye Disease

Efficacy and Safety of Teprotumumab in Patients with Active Thyroid Eye Disease (TED): A Pooled Analysis from 3 Randomized Trials (ATA 2025) - P2, P3 | "Patients receiving teprotumumab had significantly improved outcomes vs placebo. Safety observations in the integrated analysis were consistent with the individual trials."

Retrospective data • CNS Disorders • Diabetes • Ophthalmology • Thyroid Eye Disease

Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients (clinicaltrials.gov) - P=N/A | N=5 | Completed | Sponsor: Amgen | Recruiting ➔ Completed | N=10 ➔ 5

Enrollment change • Real-world evidence • Trial completion • Ophthalmology • Thyroid Eye Disease

Looking Beyond Graves: Thyroid Eye disease in Hashimoto's thyroiditis (ATA 2025) - "The management of moderate to severe TED involves intravenous (IV) steroids and monoclonal antibodies (MAB), including Rituximab, Tocilizumab, and the newer agent, Teprotumumab (TEP)...Case Presentation: A 65-year-old patient with an established diagnosis of Hashimoto's thyroiditis, on levothyroxine, presented to the hospital with three weeks of worsening diplopia and periorbital edema...The patient was subsequently started on IV methylprednisone (40 milligrams once daily) for five days and then discharged home on oral methylprednisolone (50 milligrams daily)... While thyroid eye disease is invariably associated with Grave's disease in clinical practice, our case highlights the less commonly reported association with Hashimoto's thyroiditis. Awareness of this atypical association can help physicians diagnose it early in the disease course and manage it through a multidisciplinary approach involving endocrinologists and ophthalmologists to prevent vision loss,..."

Endocrine Disorders • Grave’s Disease • Ophthalmology • Thyroid Eye Disease

The Efficacy and Safety of Teprotumumab in Geriatrics Patients: A Multicenter Study. (PubMed, Ophthalmic Plast Reconstr Surg) - "Teprotumumab is effective in reducing clinical activity score and proptosis in geriatric thyroid eye disease patients with short-term follow-up; however, high rates of adverse events, reactivation, and proptosis regression over time warrant extreme caution and selective use in this population."

Clinical • Journal • Diabetes • Geriatric Disorders • Ophthalmology • Thyroid Eye Disease

Cost-Effectiveness Analysis of Treatment Strategies for Thyroid Eye Disease: A Retrospective Cohort Analysis (ATA 2025) - "The recent incorporation of teprotumumab into medical management has expanded therapeutic options for active TED...Surgical management approaches consistently demonstrate favorable cost-effectiveness profiles compared to medical management alone. These findings support prioritizing early thyroidectomy and surgical interventions in TED treatment algorithms, to optimize preventative management and clinical outcomes."

Cost effectiveness • HEOR • Late-breaking abstract • Retrospective data • Ophthalmology • Thyroid Eye Disease