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

This trial is designed to evaluate the safety and efficacy of anti-IGF-1R mAb in combination with anti-PD-1 mAb in patients with mCRPC.

Start Date10 Mar 2025

Sponsor / Collaborator

Shanghai Changzheng Hospital

NCT06248619

/ RecruitingPhase 3

A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

Start Date05 Jul 2024

Sponsor / Collaborator

Amgen, Inc.

JPRN-jRCT2031220730

/ RecruitingPhase 3IIT

A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group Multicenter Trial to Evaluate the Efficacy and Safety of HZN-001 in Treating Japanese Participants with Chronic (Inactive) Thyroid Eye Disease

Start Date29 Mar 2023

Sponsor / Collaborator-

100 Clinical Results associated with Teprotumumab-TRBW

100 Translational Medicine associated with Teprotumumab-TRBW

100 Patents (Medical) associated with Teprotumumab-TRBW

326

Literatures (Medical) associated with Teprotumumab-TRBW

01 Jun 2025·American journal of ophthalmology case reports

Spectral-domain optical coherence tomography imaging findings in patients receiving teprotumumab for thyroid eye disease

Article

Author: Silkiss, Rona Z ; Truong, Timothy ; Li, Huanye ; Amoroso, Johnell Renz ; Hoang, Quan V ; Eliasieh, Kasra ; Jung, Jesse J

Purpose:

Prior studies have demonstrated the potential side effects of insulin-like growth factor-1 (IGF-1) inhibition for thyroid eye disease (TED) including hearing loss. In this study, we assessed changes in functional vision including visual field testing and best-corrected visual acuity (BCVA), clinical examination parameters, and spectral-domain optical coherence tomography (SD-OCT) biomarkers in patients who received insulin growth factor receptor-1 (IGF-R1) inhibition with teprotumumab for TED.

Design:

Retrospective, noncomparative cohort.

Subjects:

22 eyes of 12 TED patients.

Methods and outcomes measures:

Retrospective chart review was conducted, with demographics, clinical examination, BCVA, Humphrey visual field (HVF), and SD-OCT data: central foveal thickness (CFT), sub-foveal choroidal thickness (SFCT), choroidal vascular index (CVI), retinal nerve fiber layer (RNFL), and ganglion cell-inner plexiform layer (mGCIPL) thickness compared between before and after an 8-infusion course of teprotumumab. Linear regression modeling with clustering was used for statistical analysis. Statistical significance was set at p < 0.05.

Results:

Proptosis, clinical activity scores, and intraocular pressure improved. SFCT -35.7μm (p = 0.038), RNFL -5.41μm (p = 0.001), and mGCIPL -7.35μm (p = 0.010) decreased after six months. CFT and CVI did not statistically differ. BCVA and HVF mean deviation remained stable.

Conclusions:

There were statistically significant decreases in SFCT, RNFL, and mGCIPL in TED patients treated with teprotumumab, but no differences in CFT and CVI. Functional testing, with HVF and BCVA, was not affected, but there were significant systemic side effects including hearing loss noted in several patients. Further research is needed to understand the potential effects of IGF-1R blockade on the retina and optic nerve.

01 Jun 2025·HEARING RESEARCH

Drug-induced hearing loss: a real-world pharmacovigilance study using the FDA adverse event reporting system database

Article

Author: Zhu, Bin ; Du, Qian ; Dong, Jie ; Zhao, Zhigang ; Shi, Yanfeng ; Li, Dongxuan ; Wu, Tingxi ; Wang, Peng

Drug-induced hearing loss (DIHL) is highly prevalent, but a comprehensive picture of ototoxicity associated with drugs are still lacking. In order to comprehensively summarize the hearing safety information of current drugs, we used the real-world data from 2004 to 2023 in the FDA Adverse Event Reporting System (FAERS) database to integrate the reported ototoxicity information of drugs and applied disproportionality analysis to evaluate the hearing impairment risk induced by drugs. A total of 108,435 adverse event (AE) reports of hearing impairment were extracted from the FAERS database, involving 1300 reported culprit-drugs. On the whole, acetylsalicylic acid was the most frequently reported potential ototoxic drug, followed by levothyroxine sodium, adalimumab, omeprazole, and ergocalciferol. Immunosuppressants was the most frequently reported drug class, followed by analgesics, psychoanaleptics, agents acting on the renin-angiotensin system, and antineoplastic agents. In risk signal detection, 432 of 1300 drugs exhibited potential ototoxic risk, in which tafenoquine showed the strongest statistical correlation with hearing impairment, followed by teprotumumab, amyl nitrite, potassium iodide, and paromomycin. Among main drug classes, antibacterials for systemic use was the drug class contained the maximum number of drugs with positive ototoxic risk signals, followed by psychoanaleptics, agents acting on the renin-angiotensin system, antineoplastic agents, and analgesics. In conclusion, our study summarized a comprehensive drug list containing 1300 reported potential ototoxic drugs in the FAERS database and profiled their ototoxicity risk characteristic from the aspect of reporting frequency and risk signal strength, which can provide reference for clinical medical staff to strengthen monitoring and management of DIHL.

19 May 2025·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Comprehensive Comparisons of Different Treatments for Active Graves Orbitopathy: A Systematic Review and Bayesian Model–Based Network Meta-Analysis

Review

Author: Liu, Wei ; Huang, Liying ; Zhang, Jiaoyue ; Liu, Ruikang ; Huang, Shenyu ; Qin, You ; Xu, Yanlin

Abstract:

Context:

Graves orbitopathy is a specialized immunoinflammatory disorder related to abnormal thyroid function. Due to the complexity of the disease and its propensity to reoccur, targeted treatment is essential to improve the symptoms.

Objective:

This study aims to assess the efficacy and safety of various treatments for active thyroid eye disease.

Methods:

We conducted a comprehensive search for randomized controlled trials (RCTs), and ongoing RCTs registered on Controlled Trials, targeting treatments for thyroid eye disease until November 20, 2024. Employing a Bayesian framework, this network meta-analysis calculated risk ratios (RRs) or mean differences (MDs) with 95% CIs to size the effects for the predetermined outcomes. The study is registered with PROSPERO (CRD42024548030).

Outcome:

The primary outcomes evaluated were overall response rate, clinical activity score (CAS), proptosis, diplopia, and adverse events.

Results:

For the overall response rate, teprotumumab (RR 5.5, 95% CI 2.3 to 16), mycophenolate combined intravenous glucocorticosteroids (IVGCs) demonstrated effectiveness over no treatment, ranked from most to least effective. Notably, teprotumumab showed the highest efficacy in reducing CAS (MD −1.57, 95% CI −3.81 to 0.68) and proptosis (MD −2.29, 95% CI −2.73 to −1.86). For diplopia improvement, teprotumumab and IVGCs were effective compared with no treatment.

Conclusion:

Teprotumumab emerges as potentially the most effective treatment for reducing inflammation and increasing overall response rates when compared with no treatment; oral mycophenolate combined with IVGCs appears to be the best for improving proptosis. While some treatments raise safety concerns due to reported adverse events, oral methotrexate combined with IVGCs appear to offer a favorable balance between efficacy and safety among the evaluated treatments.

206

News (Medical) associated with Teprotumumab-TRBW

07 May 2025

·www.businesswire.com

Amgen’s TEPEZZA ® ▼ (teprotumumab) Granted Marketing Authorisation as the First Targeted Treatment Specifically for Adults With Moderate-to-severe Thyroid Eye Disease (TED) in the United Kingdom

CAMBRIDGE, England--(BUSINESS WIRE)--Today, Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for TEPEZZA® (teprotumumab) as the first therapy specifically licensed for the treatment of adult patients with moderate-to-severe Thyroid Eye Disease (TED). Affecting approximately 50,000 people in the UK,1 TED is a progressive and potentially vision-threatening condition, which can cause eye bulging, double vision, eye pain, redness and swelling.2 People living with TED often experience anxiety and depression, concerns about their facial appearance and a loss of confidence.3 This can impact their ability to work, socialise and maintain relationships.3,6 “The marketing authorisation for teprotumumab as the first therapy specifically licensed for Thyroid Eye Disease (TED) in the UK marks a step forward for the patient community,” said Dr Tony Patrikios, Executive Medical Director, Amgen UK & Ireland. “TED can negatively affect patients’ lives impacting vision, causing eye pain, making everyday tasks difficult and causing a loss of self-confidence. This authorisation introduces a new alternative treatment option and reinforces Amgen’s commitment to supporting eligible patients with serious, underserved conditions.” Teprotumumab’s marketing authorisation in the UK is supported by multiple clinical studies,5,7,8,9 including the Phase 3 clinical trial, OPTIC (n=83).5 Other clinical studies that supported the marketing authorisation in the UK include the TED01RV Phase 2 clinical study (n=88),7 the HZNP-TEP-403 Phase 4 clinical study (n=62),8 and the OPTIC-J Phase 3 study in Japan (n=54).9 In the OPTIC trial, teprotumumab demonstrated a statistically significant improvement in the primary endpoint, proptosis (eye bulging) responder rate at 24 weeks, with 83% (34/41) of patients demonstrating a reduction of at least 2mm compared to baseline, versus 10% (4/42) of patients treated with placebo (difference of 73%, 95% confidence interval, 59 to 88; P=<0.001]).5 “For adult patients living with Thyroid Eye Disease (TED), it can be challenging to receive a diagnosis and referral to specialist centres. TED is often mistaken for other more common conditions, which can be frustrating and distressing for patients. This may also lead to delays in receiving treatment. When patients are diagnosed with TED, they are currently faced with limited treatment options targeting ‘generalised inflammation’. These treatments do not specifically target the underlying cause and drivers of TED,” said Dr Jimmy Uddin, Consultant Ophthalmologist, Oculoplastic & Orbital Surgeon, Moorfields Eye Hospital and St George’s Hospital Medical School. “Teprotumumab offers eligible TED patients in the UK an important new treatment option.” The safety data for teprotumumab is based on multiple clinical studies.5,7,8,9 The most common side effects observed in clinical trials are muscle spasms (27.6%), diarrhoea (14.5%), hearing impairment (13.8%), alopecia (13.2%), hyperglycaemia (13.2%), fatigue (12.5%), nausea (10.5%), headache (10.5%), dry skin (9.9%), dysgeusia (8.6%), COVID-19 (6.6%), ear discomfort (6.6%) and nail disorder (5.9%).4 Amgen will work with the National Institute for Health and Care Excellence (NICE) to seek reimbursement of teprotumumab for all eligible patients. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Notes to Editors About Thyroid Eye Disease (TED) TED is a serious, progressive and potentially vision-threatening autoimmune disease.10 It often occurs in people living with Graves’ disease, but is a distinct disease that is caused by autoantibodies activating an insulin-like growth factor-1 receptor (IGF-1R)-mediated signalling complex on cells within the retro-orbital space.11,12 This leads to a cascade of negative effects, which may cause long-term, irreversible damage, including blindness.13,14 Early signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and double vision.2 About teprotumumab Teprotumumab is a monoclonal antibody that specifically targets and blocks the insulin-like growth factor-1 receptor (IGF-1R), which is thought to play a central role in the development of TED.15 It binds to the IGF-1R, preventing it from being activated and sending signals that lead to muscle and tissue expansion, as well as inflammation behind the eye.15 This can help reduce TED symptoms, such as proptosis (eye bulging).4,5 For further product information, please see the Summary of Product Characteristics, which will be available at: https://www.medicines.org.uk/emc About the Phase 3 OPTIC clinical trial A prospective, multi-centre randomised, double-blind, placebo-controlled, Phase 3 trial of the IGF-1R inhibitor teprotumumab or placebo in adults with Graves’ disease and active moderate-to-severe thyroid eye disease.5 83 patients between the ages of 18-80 were recruited and randomised 1:1 to receive 8 intravenous infusions of either teprotumumab or placebo. Infusions were administered every 3 weeks over 21 weeks, with a final clinical evaluation at week 24. The initial dose of teprotumumab was 10mg/kg, with each subsequent infusion dosed at 20mg/kg.5 The primary endpoint of the trial was proptosis response, defined as a reduction of at least 2mm in proptosis from baseline in the study eye without a corresponding increase of at least 2mm in the fellow (contra-lateral) eye at week 24.5 For more information on the OPTIC clinical trial go to: https://clinicaltrials.gov/study/NCT03298867. About Amgen UK Amgen’s mission is to serve patients. A biotechnology innovator since 1980, our science- based heritage is at the heart of everything we do. We remain on the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. In the UK, Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. As a regional hub, we employ around 650 people in the UK and Ireland across our commercial, R&D and corporate functions. Committed to driving sustainable solutions that can adapt to an ever-evolving health system, we are proud to serve patients every day. For more information visit: https://www.amgen.co.uk/ References 1 British Thyroid Foundation. Thyroid eye disease. Available at: https://www.btf-thyroid.org/thyroid-eye-disease/1000. Last accessed: May 2025. 2 Royal National Institute of the Blind (RNIB). Thyroid eye disease. Available at: https://www.rnib.org.uk/your-eyes/eye-conditions-az/thyroid-eye-disease/#:~:text=It%20is%20well%20known%20that,be%20taking%2C%20such%20as%20steroids. Last accessed: May 2025. 3 Smith TJ, et al. How patients experience thyroid eye disease. Front. Endocrinol. 2023;9(14):1283374. 4 TEPEZZA (teprotumumab) Summary of Product Characteristics. Will be available at: https://www.medicines.org.uk/emc 5 Douglas RS, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med 2020;382:341-352. 6 British Thyroid Foundation. Thyroid eye disease: patient leaflet. Available at: https://www.btf-thyroid.org/thyroid-eye-disease-leaflet#:~:text=You%20may%20also%20feel%20anger,both%20social%20and%20at%20work. Last accessed: May 2025. 7 Smith TJ, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. N Engl J Med 2017;376:1748-1761. 8 Douglas RS, et al. Efficacy and Safety of Teprotumumab in Patients with Thyroid Eye Disease of Long Duration and Low Disease Activity. JCEM 2024;109(1):25-235. 9 Hiromatsu Y, et al. A randomised, double-masked, placebo-controlled trial evaluating the efficacy and safety of teprotumumab for active thyroid eye disease in Japanese patients. Lancet Reg Health West Pac. 2025;55:101464. 10 Ponto KA, et al. Quality of life and occupational disability in endocrine orbitopathy. Dtsch Arztebl Int. 2009;106(17):283-289. 11 Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257. 12 Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354. 13 McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves' Orbitopathy (EUGOGO ) survey. Br J Ophthalmol. 2007;91:455-458. 14 Bartalena L, et al. The 2021 European Group on Graves’ Orbitopathy (EUGOGO) Clinical Practice Guidelines for the Medical Management of Graves’ Orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67. 15 Patel A, et al. A New Era in the Treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288.

Phase 3Clinical ResultDrug ApprovalPhase 2

02 May 2025

·www.fiercepharma.com

As Amgen's trio of Horizon drugs disappoints, execs urge analysts to give them more time

In the first quarter, sales of the top three products Amgen gained from its $27.8 billion acquisition of Horizon Therapeutics fell far short of analyst expectations, with each seeing a double-digit sequential sales decline. It’s been 19 months since Amgen completed its $27.8 billion acquisition of Horizon Therapeutics, and the California company is still struggling to build momentum for three of the prized possessions of the deal—rare disease drugs Uplizna, Krystexxa and Tepezza.When Amgen presented its first-quarter earnings Thursday, none of the trio met analyst expectations. With sales of $91 million, Uplizna came up $20 million short of the consensus projection. Meanwhile, Krystexxa’s haul of $236 million was $57 million shy of expectations, and Tepezza’s $381 million figure was $69 million off the mark.The shortfall for the Horizon products came during a quarter in which most of the company’s other treatments exceeded expectations. In fact, Amgen’s overall revenue of $8.1 billion was a 9% increase year over year and topped the analyst consensus. The lack of success for the Horizon drugs is apparently becoming a sore subject for Amgen execs. During a conference call, after an analyst asked about the stagnant sales of Tepezza and referred to a “couple years” since the Horizon buyout, Chief Financial Officer Peter Griffith was quick to make a correction.“Just a reminder that the transaction closed in October of 2023,” Griffith said. “It’s been about a year and a half, although so much has happened in the world it might feel like more than that.”The most vexing Horizon product has been with Tepezza, which remains the lone drug on the market for thyroid eye disease. In its second full year on the market under Horizon, in 2022, it generated $1.96 billion in revenue. But, in the following year, sales came in at $1.77 billion, followed by $1.85 billion last year, when there were signs that Tepezza was rallying.But the $381 million quarterly result for the treatment was a stunner—it’s lowest figure for a three-month period since the first quarter of 2021 and a 17% sequential decline.“Sales of Tepezza and Krystexxa were adversely impacted in the quarter by changes to U.S. wholesaler inventory levels," Amgen’s chief commercial officer Murdo Gordon explained. "We do not expect similar deductions in inventory levels for the remainder of the year."But the result sounded an alarm bell with Mizuho Securities analyst Salim Syed, who noted the 9% decline in volume and 8% decrease in inventory levels, which “likely put the Horizon acquisition into even more question,” he wrote in a note to investors.Gordon explained that the initial uptake of Tepezza was strong as it was a long-awaited answer for people who had serious cases of the eye disease and were readily prescribed the treatment from plastic surgeons. To grow sales, Tepezza needs to secure more prescriptions from general ophthalmologist and endocrinologists, he added.But tapping this segment of the market “may be more challenging to penetrate than previously communicated by the company,” analysts from Citi wrote in a note to clients.Amgen is far from abandoning hope for Tepezza. The company recently gained a thumbs-up from Europe’s Committee for Medicinal Products for Human Use nd is ready to launch there upon an expected approval. An additional edge Amgen could secure to help spur sales would be to earn approval for a subcutaneous version of Tepezza, as opposed to the 60- to 90-minute infusions patients undergo every three weeks as it stands. A subQ option would allow patients to receive the treatment faster and in many more settings than at infusion centers. Testing on the formulation began last year.On a much smaller scale, sales also were disappointing for Uplizna, which fell sequentially from $101 million in the fourth quarter to $91 million in the first.But help has already arrived in the form of a label expansion last month, making Uplizna the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a disease that affects 20,000 patients in the U.S. and has no standard of care. Additionally, Amgen announced Thursday that it has secured an FDA decision date of Dec. 14 for Uplizna to treat patients with generalized myasthenia gravis (gMG).With respect to all of the Horizon products, Amgen’s message on Thursday was to give them more time.“It’s a very young portfolio of products where we’re really just beginning to address the severe diseases that these drugs treat,” Jay Bradner, Amgen’s R&D chief, said. “Whether it’s Tepezza, Uplizna, Krystexxa or Tavneos, these are going to be key growth-driving products for us over the long haul.”

AcquisitionNDAClinical ResultAccelerated Approval

02 May 2025

·pharma.economictimes.indiatimes.com

Amgen posts profit, says tax policy more effective than tariffs

By Deena Beasley New York: Amgen on Thursday said its first-quarter profit rose 24%, driven by product sales, and said that while it is premature to speculate on the impact of U.S. tariffs, tax policy would be a more effective way to influence U.S. manufacturing. President Donald Trump's administration has opened a national security investigation into pharmaceuticals in a bid to demonstrate why the U.S. needs tariffs to increase domestic manufacturing. "We agree with our peers that the most effective answer is not tariffs, but tax policy," Amgen CFO Peter Griffith said on a conference call. Johnson & Johnson CEO Joaquin Duato, last month said tariffs on pharmaceuticals can create supply chain disruptions and favorable tax policies would be a more effective tool to boost U.S. manufacturing capacity of both drugs and medical devices. Pharmaceutical companies in recent decades moved production capacity outside of the U.S., including to European Union countries like Ireland, in part because of lower income-tax rates for intellectual property. Amgen recently announced a $900 million expansion of its Ohio biotech manufacturing facility, joining a number of other drugmakers, including Eli Lilly, Merck and J&J, pledging to increase U.S. plant capacity. For the first quarter, Amgen reported adjusted earnings per share of $4.90, beating the average analyst estimate of $4.30, as compiled by LSEG. Revenue rose 9 per cent to $8.1 billion, which was in line with Wall Street estimates. Shares of the biotechnology company, which fell more than 2 per cent in regular trading, were up about 1 per cent at $286 after hours. For the full year, Amgen said it still expects adjusted earnings per share of $20.00 to $21.20 on revenue of $34.3 billion to $35.7 billion. Analysts, on average, have estimated earnings of $20.63 per share on revenue of $35.1 billion. Amgen said its 2025 outlook includes the impact of implemented tariffs, but does not account for any future levies, including potential sector-specific tariffs. The company is slated to present at a medical meeting next month full results from a mid-stage trial of its experimental weight-loss drug MariTide, viewed by many investors as a potential blockbuster. Amgen is conducting late-stage trials of the drug in patients with and without diabetes, and results from a Phase 2 diabetes trial will be announced later this year. The company also said the U.S. Food and Drug Administration has lifted its clinical hold on an early-stage trial of a different experimental weight-loss drug known as AMG 513. The first-quarter results "suggest momentum for established products, but uncertainty is apparent in the newer growth portfolio, both of which highlight the importance of obesity as a future driver for shares," Citi Research analyst Geoff Meacham said in a note to clients. Amgen's sales of bone drug Prolia rose 10 per cent to $1.1 billion, but the company said it expects lower sales of the medication later in the year as biosimilar competitors are launched. Sales of cholesterol-lowering medication Repatha rose 27 per cent to $656 million, while sales of arthritis drug Enbrel fell 10 per cent to $567 million. In the rare disease space, sales of thyroid eye disease drug Tepezza fell 10% to $381 million, and sales of gout treatment Krystexxa were flat at $236 million. Both were acquired with Amgen's 2023 purchase of Horizon Therapeutics. Sales of rare disease drug Uplinza rose 14 pr cent to $91 million. Amgen said the FDA has accepted its application seeking approval of Uplinza as a treatment for myasthenia gravis, with a decision due by December 14. (Reporting By Deena Beasley Editing by Bill Berkrot and Deepa Babington)

AcquisitionDrug ApprovalPhase 2

100 Deals associated with Teprotumumab-TRBW

External Link

KEGG	Wiki	ATC	Drug Bank
-	Teprotumumab-TRBW	L01XC	DB06343

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Graves Ophthalmopathy	United States	Horizon Therapeutics Ireland DAC	21 Jan 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	United States	Hoffmann-La Roche, Inc.	28 Jan 2009
Advanced Lung Non-Small Cell Carcinoma	Phase 2	United States	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Australia	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Belgium	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Canada	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	France	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Germany	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Ireland	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Italy	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Poland	Hoffmann-La Roche, Inc.	10 Nov 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ENDO2024	Not Applicable	Osteoarthropathy, Primary Hypertrophic TSH receptor \| IGF-1 receptor	-	Teprotumumab	bpwtimdugu(ojtorhllih) = uqxvxnpjes midnkbiavi (ruezvbomtf )	Positive	01 Jun 2024
OPTIC and OPTIC-X (ENDO2024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	pcpotufqpw(jwrmqhekwe) = jqiiehvesb orgmbbcrtl (ydcbmozzge ) View more	Positive	01 Jun 2024
ENDO2024	Not Applicable	Hyperglycemia HbA1c	-	Teprotumumab 10 mg/kg	xscffgjkdt(jsgrnrdmef) = ohemrkwvsh jsfpsgsmuq (nxzsehbcde ) View more	Negative	01 Jun 2024
ENDO2024	Not Applicable	Hyperglycemia HbA1c	-	Metformin	xscffgjkdt(jsgrnrdmef) = abnwazjyjf jsfpsgsmuq (nxzsehbcde ) View more	Negative	01 Jun 2024
NCT01868997 \| NCT03298867 \| JPRN-jRCT2031210453 (Three Global Randomized, Double-masked, Placebo-controlled Trials, ENDO2024)	Not Applicable	Graves Ophthalmopathy	-	Teprotumumab	zxnktkwjdr(zzlyabexms) = pwizhthknp txhwsjxxdt (yogvagvfdm )	Positive	01 Jun 2024
	Not Applicable	Graves Ophthalmopathy	-	Placebo	zxnktkwjdr(zzlyabexms) = khkadltshv txhwsjxxdt (yogvagvfdm )	Positive	01 Jun 2024
OPTIC and OPTIC-X (ENDO2024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	ephssutoyn(xyeavhgoax) = umyjyewgpg mudrfudkdq (upsgkwnaes ) View more	Positive	01 Jun 2024
ENDO2024	Not Applicable	Hyperglycemic Hyperosmolar Nonketotic Coma HbA1c \| Thyroid Stimulating Immunoglobulin	-	Teprotumumab	sfcyfpphkj(bxnekqtgle) = one patient with pre-existing prediabetes developing diabetic ketoacidosis (DKA) hkgyheplud (ozydrzceyq ) View more	Negative	01 Jun 2024
ENDO2024	Not Applicable		-	Insulin		Negative	01 Jun 2024
NCT04478994 (CTgov)	Phase 1	Scleroderma, Diffuse	3	Placebo	oniqjrvqhl = rbwchbybae uqubqcmdho (iixadcknxz, krzyohoico - uanelhzrpm) View more	-	19 Apr 2024
NCT04583735 (OR27-04, ENDO2023)	Phase 4	Graves Ophthalmopathy	62	Teprotumumab	amhxvqrdmn(unjoktefow) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) zxlzqomqhf (owmjmmripo ) View more	Positive	05 Oct 2023
NCT04583735 (OR27-04, ENDO2023)	Phase 4	Graves Ophthalmopathy	62	Placebo		Positive	05 Oct 2023
ARVO2023	Not Applicable	Graves Ophthalmopathy	19	Teprotumumab	vjbemsdcrm(cjzsfxnsns) = rqesyhapxj vrsjqipjfe (ggatuhgenn ) View more	-	23 Apr 2023
PSAT355 (ENDO2022)	Not Applicable	Myasthenia Gravis \| Graves Ophthalmopathy	-	Teprotumumab	nbohkxjomk(erwrckismw) = rfjhwtytno mbprgtfylv (lcdvncrehg )	-	01 Nov 2022

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