Sycume (teprotumumab N01) / Innovent Biologics - LARVOL DELTA

Efficacy and Safety of IGF-1 Receptor Inhibitors for Thyroid Eye Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. (PubMed, Drugs) - "IGF-1R inhibitors outperformed placebo across multiple efficacy outcomes. These findings confirm their robust efficacy in TED, particularly in active disease. Given the increased adverse event risk, IGF-1R inhibitors warrant vigilant monitoring, including baseline and on-treatment glycemic and audiometric assessments, to ensure optimal safety."

Journal • Retrospective data • Review • Ophthalmology • Thyroid Eye Disease • IGF1

A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease (clinicaltrials.gov) - P4 | N=92 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2027 ➔ Dec 2028 | Initiation date: Dec 2025 ➔ Jul 2026 | Trial primary completion date: Sep 2026 ➔ Jun 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Marked and reversible circulating insulin-like growth factor-1 elevation during teprotumumab N01 treatment for thyroid eye disease with limited correspondence to glycemic changes. (PubMed, Front Endocrinol (Lausanne)) - "Similar findings were observed in subgroup and HbA1c quartile analyses. Teprotumumab N01 treatment was associated with a substantial, early, and broadly reversible increase in circulating IGF-1 in patients with moderate-to-severe TED, but IGF-1 dynamics did not serve as an independent indicator of glycemic deterioration."

Biomarker • Journal • Retrospective data • Diabetes • Ophthalmology • Thyroid Eye Disease • IGF1

Head-to-Head Comparison of an IGF-1R Inhibitor Versus Intravenous Glucocorticoid for Active Thyroid Eye Disease: Design of a Randomized Clinical Trial. (PubMed, Ophthalmol Ther) - P4 | "Participants will be randomized 1:1 to receive either intravenous teprotumumab N01 (10 mg/kg initial dose on day 1, followed by 20 mg/kg at weeks 3, 6, 9, and 12) or IVGC pulse therapy (methylprednisolone 500 mg on day 1 and from week 1 to week 5, followed by 250 mg from week 6 to week 11). It aims to address the limitations of IVGC, including its uncertain efficacy on proptosis and diplopia, by utilizing a targeted approach to provide more comprehensive clinical evidence for TED treatment. ClinicalTrials.gov identifier, NCT07265258 (RESTORE-4)."

Clinical • Head-to-Head • Journal • Immunology • Ophthalmology • Thyroid Eye Disease

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=91 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Thyroid Eye Disease

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=91 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Sep 2025 | Trial primary completion date: May 2026 ➔ Sep 2025

Trial completion • Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Efficacy and Safety of IBI311 in Thyroid Eye Disease (TED) Poorly Responsive to Glucocorticoids: A Randomized, Double-Masked, Placebo-Controlled Trial (AACE 2026) - "Among participants with active TED, IBI311 achieved a higher overall response rate (CAS reduction ≥2 and proptosis reduction ≥2 mm, Discussion/Conclusion For patients with moderate-to-severe TED with a poor response to glucocorticoid therapy, IBI311 demonstrated significant efficacy in alleviating proptosis and disease activity, while well tolerated. These findings support insulin-like growth factor-1 receptor inhibitor as a promising treatment option for this unmet clinical population."

Clinical • Ophthalmology • Thyroid Eye Disease

A Multi-center, Open-label, Extension Study to Evaluate the Efficacy and Safety of Teprotumumab N01 (IBI311) in Participants with Thyroid Eye Disease (AACE 2026) - "Methods Participants in the phase 2/3 study of IBI311 (study A201) could be enrolled in this extension study (study A301), including an off-treatment observation period, an open-label treatment period (C1-C8) followed by a safety follow-up period. Moreover, patients with TED who experienced a disease flare after IBI311 treatment can still benefit from IBI311 retreatment. The overall safety profile was favorable during the study."

Clinical • Ophthalmology • Thyroid Eye Disease

A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of tiotropium bromide N01 injection in the treatment of newly diagnosed patients with thyroid eye disease who have strabismus (ChiCTR) - P=N/A | N=90 | Sponsor: The Zhongshan Ophthalmic Center,Sun Yat-sen University; The Zhongshan Ophthalmic Center,Sun Yat-sen University

New trial • Ophthalmology • Strabismus • Thyroid Eye Disease

Teprotumumab N01 for thyroid eye disease in China: clinical outcomes and quantitative MRI correlations. (PubMed, Front Med (Lausanne)) - "In this real-world Chinese cohort, teprotumumab N01 was associated with concordant clinical improvement and quantitative MRI changes. IR-focused morphologic measures and diffusion-derived ADC showed the most consistent associations with changes in proptosis and disease activity, supporting their further evaluation for treatment monitoring in TED."

Clinical data • Journal • Ophthalmology • Thyroid Eye Disease • IGF1

A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy (clinicaltrials.gov) - P3 | N=53 | Completed | Sponsor: Peking University People's Hospital | Active, not recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ Jul 2025

Trial completion • Trial completion date • Ophthalmology • Thyroid Eye Disease

Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease. (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Peking University Third Hospital

New trial • Ophthalmology • Thyroid Eye Disease

Evaluation of efficacy and safety of teprotumumab combined with glucocorticoids in the treatment of moderate to severe active thyroid eye disease (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Tianjin Medical University General Hospital; Tianjin Medical University General Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

In the updated NRDL, SYCUME (teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease (PRNewswire) - "SYCUME (teprotumumab N01 injection) is China's first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China."

Reimbursement • Thyroid Eye Disease

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

A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=111 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • 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

A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Sep 2025 | Trial primary completion date: Aug 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment. (clinicaltrials.gov) - P4 | N=96 | Recruiting | Sponsor: Shanghai Changzheng Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment. (clinicaltrials.gov) - P4 | N=64 | Recruiting | Sponsor: Shanghai Changzheng Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Shanghai Changzheng Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=111 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Ophthalmology • Thyroid Eye Disease

Efficacy and Safety of Teprotumumab N01 Injection in Subjects with Thyroid Eye Disease Exhibiting Significant Extraocular Muscle Inflammation on MRI but with CAS Scores in the Inactive Phase (ChiCTR) - P=N/A | N=15 | Not yet recruiting | Sponsor: Department of Ophthalmology, West China Hospital, Sichuan University; Department of Ophthalmology, West China Hospital, Sichuan University

New trial • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease