Delving into the Latest Updates on Teprotumumab-TRBW with Synapse

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia), Fast Track (United States)

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Structure/Sequence

Sequence Code 140450L

Source: *****

Sequence Code 140493H

Source: *****

The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED).
The main question it aims to answer is:
* Is a shorter course equally effective and safe for patients who respond well early in treatment.
Participants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.

Start Date01 Jan 2026

Sponsor / Collaborator

Sheba Medical Center

ChiCTR2500108068

/ Not yet recruitingNot ApplicableIIT

Clinical outcome of Anti-IGF-1R monoclonal antibody(Teprotumumab) for the treatment of thyroid eye disease.

Start Date31 Aug 2025

Sponsor / Collaborator-

NCT07142642

/ CompletedPhase 1

A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.

Start Date26 Aug 2025

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Teprotumumab-TRBW

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100 Translational Medicine associated with Teprotumumab-TRBW

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100 Patents (Medical) associated with Teprotumumab-TRBW

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373

Literatures (Medical) associated with Teprotumumab-TRBW

01 Apr 2026·Ophthalmology science

A Deep Learning Framework for Predicting Teprotumumab Treatment Response in Thyroid Eye Disease

Article

Author: Langarica, Saul ; Lee, Nahyoung Grace ; Alkhadrawi, Adham M ; Kim, Young-Tak ; Lin, Lisa Y ; Ha, Sierra K ; Do, Synho

Purpose:

To develop and evaluate a deep learning-based framework for quantifying thyroid eye disease (TED) severity before and after teprotumumab treatment, an insulin-like growth factor-1 receptor inhibitor, and to create a predictive model for forecasting individual patient responses to therapy.

Design:

A retrospective cohort study was conducted at a single institution, utilizing an image-based deep learning TED severity quantification model and a regression-based prediction model for teprotumumab treatment response.

Subjects:

One hundred eighty-four patients with a clinical diagnosis of TED and 44 individuals with normal orbital anatomy (controls) used for model training and validation. Additionally, 19 patients with pretreatment and posttreatment imaging were analyzed for treatment response.

Methods:

A deep learning classification model integrating computed tomography-based orbital volumetric features and clinical data were developed to classify TED severity (normal, mild, and severe). A severity scoring model converted classification probabilities into a continuous severity metric. A regression-based model then predicted posttreatment severity using pretreatment clinical and imaging variables. Model performance was evaluated using accuracy, area under the receiver operating characteristic curve (AUC), root mean squared error, and coefficient of determination (R ² ).

Main Outcome Measures:

Thyroid eye disease severity scores and predicted treatment response.

Results:

The classification model achieved an accuracy of 0.81 and an AUC of 0.88 in the primary cohort and an accuracy of 0.81 with an AUC of 0.86 in the treatment response cohort. Within the treatment response group (n = 19), a mean improvement of 0.194 severity points (P < 0.001) was observed after teprotumumab. The regression-based prediction model achieved a root mean squared error of 0.117 and an R ² of 0.82 in leave-one-out cross-validation and showed 89% concordance with clinician-assessed improvement.

Conclusions:

This deep learning framework demonstrates promising performance for objective TED severity quantification and exploratory prediction of teprotumumab treatment response. By integrating clinical and imaging data, this approach provides a proof-of-concept for data-driven tools that may support individualized treatment planning in TED.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

01 Mar 2026·American journal of ophthalmology case reports

Extraocular muscle volume reduction in a patient treated with two courses of teprotumumab for thyroid eye disease

Article

Author: Routzong, Megan ; Granet, David ; Kikkawa, Don O ; Rudell, Jolene C ; Richkind, Hanna ; Shoji, Marissa K

Purpose:

To report magnetic resonance imaging (MRI) extraocular muscle (EOM) volume analysis in a patient with thyroid eye disease (TED) who was treated with two full courses of teprotumumab.

Observations:

An 84-year-old man with TED received two full courses (16/16 infusions) of teprotumumab. At the initial presentation, he had decreased visual acuity, proptosis, and diplopia. Imaging at this time illustrated enlarged EOMs, predominantly on the left side. After his first course of teprotumumab, his symptoms improved. However, he experienced disease reactivation 7 months later. A follow-up MRI revealed reduced EOM volume compared to baseline, though the patient reported recurrent symptoms. A second course of teprotumumab (8/8 infusions) was initiated, leading to clinical improvement. Six months after completion of his second teprotumumab course, a third MRI showed further reduction in EOM volumes compared to both baseline and pre-retreatment imaging.

Conclusion:

This case demonstrates the potential for continued radiographic and clinical improvement in TED patients after retreatment with teprotumumab. Further studies may clarify the role of EOM volume as a marker for treatment efficacy.

01 Feb 2026·Laryngoscope Investigative Otolaryngology

Teprotumumab for Thyroid Eye Disease: Efficacy and Impact on Orbital Decompression Utilization

Article

Author: Jategaonkar, Gaurav ; Lança Gomes, Pedro ; Miglani, Amar ; Marino, Michael J. ; Lal, Devyani ; Kumar, Nitish

ABSTRACT:

Objectives:

We evaluated the impact of teprotumumab therapy ( TT ) introduction on orbital decompression ( OD ) utilization for thyroid eye disease ( TED ) and compared rates of significant exophthalmos reduction ( SER ) and diplopia between TT and OD .

Methods:

Newly diagnosed TED patients treated pre (2015–2020) and post teprotumumab (2020–2025) FDA approval were identified from the EHR . Utilization trends, diplopia rates, and immediate (≤ 6 weeks post‐intervention) and long‐term follow‐up SER (≥ 2 mm reduction) were studied.

Results:

Of 406 TED patients, 53 (36.8%) underwent OD in the pre‐ TT cohort ( n = 144). Post‐teprotumumab approval ( n = 262), primary OD was performed in 29 (11.1%), of which 3 (10.3%) were subsequently placed on TT ; primary TT was used in 68/262 (25.9%) with subsequent OD performed in 9 (13.2%). The remaining patients used other treatments (corticosteroids, orbital radiation, rituximab, tocilizumab, etc.). In the overall cohort, immediate SER was achieved in 94.4% of OD versus 83.8% of TT patients ( p = 0.028), with greater median reduction in the OD group (5 vs. 4 mm; p = 0.001). At long‐term follow‐up (median 13 vs. 12 months), SER was sustained in 85.4% of OD and 62.9% of TT patients ( p = 0.042). Pre‐therapy diplopia was more prevalent in TT vs. OD patients (79.4% vs. 59.7%; p = 0.019). New‐onset posttreatment diplopia was higher in the OD group (20.7% vs. 5.9%; p = 0.008).

Conclusions:

Rates of OD surgery declined following FDA approval of teprotumumab. OD achieved sustained and greater exophthalmos reduction but carried a higher risk of diplopia. Contemporaneous OD indications may have evolved to use in TT‐recalcitrant TED or those in need of urgent decompression.

Level of Evidence:

4.

229

News (Medical) associated with Teprotumumab-TRBW

30 Mar 2026

·www.fiercebiotech.com

Viridian’s other rival to Amgen’s Tepezza scores phase 3 win, but investors need convincing

Jefferies analysts predicted “fierce investor debate on commercial feasibility” based on the drug’s failure to beat Tepezza based on a cross-trial comparison.\n Not content with lining up one potential rival to Amgen’s Tepezza, Viridian Therapeutics has scored a phase 3 win for another thyroid eye disease (TED) prospect. But the candidate\'s inability to meet investors’ expectations has cast a shadow over the results.Viridian evaluated the anti-IGF-1R antibody elegrobart in a late-stage study of 132 patients with TED. Patients received the injected treatment every four weeks or every eight weeks, or placebo.The study’s primary endpoint was the proptosis responder rate (PRR)—the proportion of people who experienced at least a 2 mm reduction in bulging eye—among participants on the monthly dosing regimen at week 24. The study hit this endpoint, demonstrating a responder rate of 54% compared to 18% for the placebo cohort, according to a March 30 release.Among the cohort who were dosed every eight weeks, the PRR was 63%.On the secondary endpoint of the mean change in proptosis at baseline among the monthly dosing cohort, Viridian reported a mean reduction of 2.33 mm compared to 0.81 mm in the placebo group.Meanwhile, Viridian reported the complete resolution of diplopia, the medical term for double vision, in 51% of patients on monthly elegrobart, compared with 16% of their peers in the placebo group. Viridian CEO Steve Mahoney touted this morning’s results as the “largest pivotal clinical trial conducted in active TED to date.”“REVEAL-1 met its primary endpoint with high statistical significance,” Mahoney continued. “Elegrobart treatment drove robust proptosis responses in a treatment regimen comprised of as few as three subcutaneous doses.”Amgen’s Tepezza is already on the market for TED, but Viridian is hoping that it can gain an edge because elegrobart is injected rather than administered as an intravenous infusion.“Currently, the only marketed treatment for TED requires eight intravenous infusions and, despite low market penetration, annualized in 2025 to approximately $2 billion in revenues,” Mahoney said in the release. “We believe there is a significant opportunity with subcutaneous elegrobart in TED, including the potential to expand the market as an at-home and self-administered treatment option, if approved.” While Jefferies analysts acknowledged elegrobart hit the trial’s endpoint this morning, they predicted “fierce investor debate on commercial feasibility” based on the drug’s inability to beat Tepezza in a cross-trial comparison. At 36%, elegrobart’s placebo-adjusted PRR was below the 50% bar expected by investors and didn’t reach the 51% seen in a trial of Amgen’s blockbuster, the analysts pointed out in a March 30 note.Elegrobart’s objective PRR of 54% also fell below the 70% seen by Viridian’s veligrotug, another Tepezza-rivalling anti-IGF-1R antibody. Elegrobart has the same binding domain as veligrotug and was engineered to have a longer half-life.The FDA is due to decide on whether to approve veligrotug for TED by June 30.This uncertainty of whether elegrobart can take on Tepezza in a fair fight was reflected in investors’ reaction this morning, with Viridian’s stock opening down 33% at $18.31 in pre-market trading Monday from a Friday closing price of $27.39.Evercore ISI analysts were more forgiving, however, suggesting today’s readout “meets our base case,” although they acknowledged that the absolute PRR was on the “low end” of their expected range.When it came to safety, Viridian said elegrobart was generally well-tolerated with “adverse events generally expected from the anti-IGF-1R class, the vast majority of which were mild.” Placebo-adjusted rates of hearing impairment—which has been tied to anti-IGFR drugs—were 11.3% in the monthly dosing cohort and 2.3% in those dosed every eight weeks.The Massachusetts-based biotech is running another phase 3 trial of elegrobart in chronic TED, with a readout due in the second quarter. The company’s plan is to submit an approval filing for the drug with the FDA in the first quarter of next year.

Phase 3Clinical ResultDrug Approval

30 Mar 2026

·endpoints.news

Viridian’s autoimmune eye disease shot passes Phase 3, but can it compete with Amgen?

Viridian Therapeutics’ shares dropped Monday morning after a lackluster pivotal readout on its injection to treat thyroid eye disease. Viridian’s pitch is that its drug, known as elegrobart, comes as an injection that can be administered at home by patients themselves, whereas its main competitor, Amgen’s Tepezza, comes as an IV infusion that has to be given by a healthcare professional. While elegrobart succeeded in the Phase 3 study, its results didn’t look as good as Tepezza’s. Viridian’s shares $VRDN fell 33% following the data disclosure. Viridian reported two primary endpoints for its Phase 3 study, one that will be used for FDA approval and the other for EU approval. The once-monthly shot substantially cut proptosis, or bulging of the eye, in 54% of patients compared to 18% with placebo. That translates to a 36 percentage-point improvement over placebo. A shot of Viridian’s treatment given once every two months led to proptosis response in 63% of patients compared to 18% with placebo. By comparison, infusions of Tepezza led to a 73% improvement in proptosis response rate over placebo. Viridian itself has also developed an IV infusion for thyroid eye disease that is awaiting FDA approval. That asset, known as veligrotug, led to a placebo-adjusted proptosis response rate of 64% . The FDA is expected to make a decision on veligrotug by June 30. “We expect fierce investor debate on commercial feasibility given efficacy underperformed comps,” Jefferies analyst Faisal Khurshid said. On the second primary endpoint for EU approval, 51% of patients who received elegrobart responded to treatment compared to 16% with placebo. On safety, Viridian said that rates of hearing impairment were low, at 11.3% and 2.3% adjusted for placebo, for the shot given once a month and once every two months. Hearing impairment is a notable side effect for the class of drugs, known as anti-IGF-1R. Viridian said it expects topline data from a second pivotal Phase 3 study of elegrobart in chronic thyroid eye disease to read out in the second quarter of the year, and it expects to submit an application for FDA approval in the first quarter of 2027.

Phase 3Clinical Result

30 Mar 2026

·firstwordpharma.com

Viridian's Phase III win for subcutaneous Tepezza rival falls flat with investors

Viridian Therapeutics is looking to make elegrobart (VRDN 003) the first subcutaneous autoinjector treatment for thyroid-eye disease (TED), but investors are yet to be convinced, sending shares down 32% Monday despite the company touting positive Phase III results.Top-line data from the REVEAL-1 trial showed that elegrobart, a half-life-extended monoclonal antibody targeting IGF-1R, met its primary endpoint with statistically significant reductions in proptosis. The therapy offers a similar approach to Amgen's intravenous drug Tepezza (teprotumumab), but in a more convenient format."Elegrobart treatment drove robust proptosis responses in a treatment regimen comprised of as few as three subcutaneous doses," said CEO Steve Mahoney in a company release. He noted that Tepezza requires eight intravenous infusions, and is currently the only approved TED treatment on the market, bringing in about $1.9 billion in sales last year "despite low market penetration."Viridian's REVEAL-1 study enrolled 132 patients with active TED, randomised to every-four-week (Q4W) dosing, every-eight-week (Q8W) dosing, or placebo. The primary endpoint for US regulators was Q4W proptosis responder rate (PRR); it was Q4W overall response rate (ORR) for regulators in the EU.At week 24, PRR reached 54% for the Q4W cohort and 63% for the Q8W cohort, compared to 18% for placebo. ORR outcomes were 51% and 58% for the two treatment arms, respectively, versus 16% for placebo.On average, patients in the Q4W and Q8W groups had placebo-adjusted proptosis improvements of 1.52 mm and 1.69 mm, respectively.Market underwhelmedHowever, the REVEAL-1 results appear to have fallen below expectations. "The less frequent regimen delivered a better profile between the two," commented Oppenheimer analyst Leland Gershell, "but we are underwhelmed by the overall efficacy profile of both."Ahead of the readout, analysts at Jefferies suggested that a placebo-adjusted proptosis response of at least 50% "should clear the bar in our view." They added that "physicians/patients should be comfortable trading some efficacy for at-home [subcutaneous] dosing,particularly in chronic and moderate TED."Tepezza was approved in 2020 based on the Phase III OPTIC study, which showed that nearly 83% of treated patients achieved at least a 2-mm reduction in proptosis, versus about 10% for placebo.Meanwhile, Viridian said diplopia outcomes in REVEAL-1 also favoured elegrobart, with respective complete resolution rates of 51% and 28% for Q4W and Q8W patients, versus 16% on placebo, though the results weren't statistically significant.Adverse events (AEs) were mostly mild and consistent with the profile "generally expected" from the IGF-1R class, according to the company. Placebo-adjusted hearing impairment rates were 11.3% in the Q4W arm and 2.3% in the Q8W arm, all of which were cases of tinnitus without associated hearing loss.Attention now turns to a second Phase III study, REVEAL-2, only this time in chronic TED patients; a top-line readout is expected in the second quarter. Viridian said it plans to submit a marketing application for elegrobart in early 2027.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Teprotumumab-TRBW

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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

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Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2025	Not Applicable	Graves Ophthalmopathy	51	Teprotumumab	hwxkdarpwn(shnmichhpf) = xdimzfhfxk fzzmkdycmu (qtnmoubqud, 1.8) View more	Positive	04 May 2025
NCT01868997 \| NCT03298867 \| JPRN-jRCT2031210453 (Three Global Randomized, Double-masked, Placebo-controlled Trials, ENDO2024)	Not Applicable	Graves Ophthalmopathy	-	Teprotumumab	gorsxalpos(amqrpmmboz) = vtmreuuhua kruegijocb (yfsvmwdjrr )	Positive	01 Jun 2024
				Placebo	gorsxalpos(amqrpmmboz) = qfucqfohvp kruegijocb (yfsvmwdjrr )
ENDO2024	Not Applicable	Graves Ophthalmopathy TSH \| T4 \| Total T3 ... View more	26	Teprotumumab	eidcpzfrkx(zudxwtxcxi) = 19% kzblmvucge (wehnjwxvez ) View more	-	01 Jun 2024
OPTIC and OPTIC-X (ENDO 12024 \| ENDO 22024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	bwjbeyqcbw(gnzrnhmkvr) = betivzjnit kzsqaxqdsa (pffdtijnhd ) View more	Positive	01 Jun 2024
OPTIC and OPTIC-X (ENDO 12024 \| ENDO 22024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	pwpdskzlno(abjqydeyek) = tlkpkalmsl aznfowocdm (rsfqnymbli ) View more	Positive	01 Jun 2024
NCT04478994 (CTgov)	Phase 1	Scleroderma, Diffuse	3	Placebo	hblqcibqya = sbvyopcgvw suelqpzxud (hlsltewyfe, lovggwedzb - nkayyajsiu) View more	-	19 Apr 2024
Pubmed \| Ophthalmic Plast Reconstr Surg Manual	Not Applicable	Graves Ophthalmopathy	66	Teprotumumab	hhldatxken(qnfswttuza) = xjplxeblqf ljnqjrbehn (ijkipbytac ) View more	Positive	16 Nov 2023
				Teprotumumab (Patients who underwent prior decompression surgery)	hhldatxken(qnfswttuza) = fgrxqyflku ljnqjrbehn (ijkipbytac ) View more
NCT04583735 (OR27-04, ENDO2023)	Phase 4	Graves Ophthalmopathy	62	Teprotumumab	dnmgshacbh(lzmustmldp) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) iscxyculia (kbgchdxpym ) View more	Positive	05 Oct 2023
				Placebo
OPTIC (Phase 3) And OPTIC-X Pivotal Trials (ENDO2023)	Phase 2/3	-	-	Teprotumumab	pjtvbellyj(nzgddmtjan) = mixucbggyu fcxqefcxoq (orxwplwbdi ) View more	Positive	05 Oct 2023
				Placebo	pjtvbellyj(nzgddmtjan) = iuozqorxno fcxqefcxoq (orxwplwbdi ) View more
RF35 \| PSAT263 (ENDO2022)	Phase 2/3	Graves Ophthalmopathy low baseline FT4 levels	17	Teprotumumab	kyajjewvvk(qhqquswnoy) = hlefuuzhqy dlatmoxqhm (mffrrtnndz ) View more	Positive	01 Nov 2022
				Placebo	kyajjewvvk(qhqquswnoy) = qjhjfqoftc dlatmoxqhm (mffrrtnndz ) View more

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