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

Structure/Sequence

Sequence Code 140450L

Source: *****

Sequence Code 140493H

Source: *****

Clinical Trials associated with Teprotumumab-TRBW

NCT07308964

/ Not yet recruitingPhase 4IIT

A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response

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

/ SuspendedNot 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

100 Translational Medicine associated with Teprotumumab-TRBW

100 Patents (Medical) associated with Teprotumumab-TRBW

375

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: Granet, David ; Routzong, Megan ; 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:

246

News (Medical) associated with Teprotumumab-TRBW

06 May 2026

·www.biospace.com

Viridian turns green again as new Phase 3 data vindicate thyroid eye disease drug

iStock, Baurzhan Ibrashev Viridian Therapeutics’ elegrobart normalized the degree of eye protrusion and improved double vision in a Phase 3 study. The company plans to approval in the first quarter of 2027. Viridian Therapeutics’ thyroid eye disease drug significantly normalized the degree of eye protrusion in a Phase 3 study of thyroid eye disease, setting the stage for a potential comeback in this indication. In REVEAL-2, data from which were unveiled in a news release on Tuesday , one dose of elegrobart every four weeks resulted in a proptosis responder rate (PRR) of 50%, versus 15% for placebo at 24 weeks. Proptosis refers to the abnormal protrusion of the eyes, a common symptom in thyroid eye disease (TED). The treatment effect was statistically significant in favor of elegrobart. The same was true for treatment given every eight weeks, with a PRR of 54%. Alongside proptosis response, Viridian on Tuesday also touted positive benefits of elegrobart for double vision, or diplopia. “We believe these results strengthen the clinical pro elegrobart,” analysts at William Blair told investors on Tuesday. “With two positive, large Phase III studies now in hand, elegrobart looks approvable and commercially competitive.” These results point to elegrobart’s “IV-like efficacy in a convenient, self-administered subcutaneous therapy with as few as four administrations” for a complete course, the analysts added. Truist Securities was more direct about elegrobart’s competitive edge, writing in a Tuesday note that the drug’s “more-convenient offering could bring a large proportion of the TED patients off the sidelines.” Approximately 30% of patient candidates for Amgen’s Tepezza “opt to stay off therapy given the logistical/administrative burden,” the analysts added. Elegrobart, if approved, could provide these patients with a more acceptable treatment option. Immunology and inflammation Viridian Turns Red as Thyroid Eye Disease Data Disappoint Despite hitting its primary endpoint, Viridian’s thyroid eye disease antibody failed to ease eye bulging to the degree that analysts had been hoping for, and the biotech’s stock price fell by one-third. March 31, 2026 · 2 min read · Tristan Manalac Read more The new data vindicate the company and elegrobart, after an underwhelming readout in March from the Phase 3 REVEAL-1 trial, which found placebo-adjusted PRR ranging from 36% to 45%, falling behind the investor expectation of 51% to 73%. Viridian’s stock crashed by as much as 33% in the aftermath of these results. With Tuesday’s new data , however, the biotech soared nearly 39% to $18.75 by market close yesterday, though the price bump still isn’t enough to recoup Viridian’s initial loss in March. Viridian plans to approval package for elegrobart in the first quarter of 2027, according to its Tuesday release.

Phase 3Financial StatementClinical Result

05 May 2026

·firstwordpharma.com

Viridian's elegrobart clears second late-stage hurdle in TED

Shares in Viridian Therapeutics jumped as much as 34% Tuesday after the company reported positive top-line results from its second Phase III trial of elegrobart, bolstering the company's bid to bring a subcutaneous alternative to market for thyroid eye disease (TED).The REVEAL-2 study, conducted in patients with chronic TED, showed that the half-life-extended monoclonal antibody targeting IGF-1R significantly improved both proptosis responder rate (PRR) and overall responder rate (ORR), the primary endpoints for US and EU regulators, respectively.In March, Viridian said its drug had succeeded in another Phase III study, REVEAL-1, involving patients with active TED, though that dataset drew a negative investor response at the time, with some analysts saying the efficacy profile had fallen short of expectations.'IV-like proptosis response'REVEAL-2 enrolled 204 patients with chronic TED and evaluated two dosing regimens against placebo. According to Tuesday's readout, elegrobart achieved PRRs of 50% and 54% at week 24 in the every-four-week (Q4W) and every-eight-week (Q8W) dosing arms, respectively, versus 15% for placebo. The corresponding ORRs were 47% for the Q4W arm and 54% for the Q8W arm, compared to 15% for placebo.Proptosis mean change from baseline was also significant at -1.9 mm and -2.1 mm in the Q4W and Q8W dosing arms, respectively, versus -0.5 mm for placebo.Additionally, the drug demonstrated a statistically significant improvement in diplopia in the more frequent Q4W dosing arm, with a 61% response rate (p = 0.0118), including 44% who achieved complete diplopia resolution. The diplopia responder rate was 55% for the Q8W group (p = 0.0419) and 38% for placebo."Given the IV-like proptosis response and our plans to launch with an at-home autoinjector, we believe elegrobart can meaningfully attract chronic patients to seek treatment," said CEO Steve Mahoney in a company release Tuesday.Safety findings were consistent with the IGF-1R class, with most side effects classified as mild and no treatment-related serious adverse events. Viridian added that rates of hearing impairment were low across both treatment arms, with placebo-adjusted rates of 4.1% and 8.8% in the Q4W and Q8W groups, respectively.Filing planned for early 2027The therapy offers a similar approach to Amgen's IV drug Tepezza (teprotumumab), currently the only approved drug for TED, but in a more convenient format.However, Amgen recently reported a late-stage win for a subcutaneous formulation of Tepezza showing proptosis response rates near 77%. That programme aims to extend the reach of its already established IV therapy that generated roughly $1.9 billion in sales last year.Viridian said it remains on track to submit a marketing application for elegrobart to the FDA in the first quarter of 2027. Meanwhile, the company is also preparing for the planned US launch of its lead TED programme, veligrotug. That drug is currently under priority review at the FDA with a decision deadline set for June 30.

Phase 3Clinical ResultPriority Review

05 May 2026

·www.biopharmadive.com

Viridian data lift prospects for thyroid eye disease drug

Viridian Therapeutics said Tuesday its injectable drug for thyroid eye disease scored in a second late-stage trial, strengthening its position as a competitive threat to Amgens blockbuster therapy Tepezza.Viridian has already disclosed that its drug, an under-the-skin injection called elegrobart, met its objectives in a study of people with acute thyroid eye disease. On Tuesday, the company claimed success in another late-stage trial of people whose disease has transitioned to a chronic phase.According to Viridian, once-monthly and every-other-month doses of elegrobart were associated with response rates of 50% and 54%, respectively, after 24 weeks. By comparison, 15% of placebo recipients hit that mark, a difference the immune drugmaker described in its statement as highly statistically significant.The once-monthly dose of elegrobart also helped relieve cases of double vision, or diplopia, with 61% of those getting the drug responding versus 38% of people in the control group. The longer-lasting dose missed statistical significance, Viridian said.The vast majority of side effects associated with treatment were mild and generally in line with whats expected of drugs in Viridians class. Rates of hearing impairment an issue with Tepezza were low in both dose groups. Among people who got the drug, 91% completed their full course, and investigators didnt observe any treatment-related serious adverse events.Viridian is on track to seek regulatory clearance by the first quarter of next year.The results represent a needed boost for Viridian, which is aiming to break into a market currently dominated by Amgen but has faced investor doubts about its prospects.Amgens Tepezza is currently the only approved treatment for thyroid eye disease,an autoimmune condition that can cause eye bulging, redness and double vision. It regularly generates about $2 billion in annual sales.Viridian is among the companies aiming to top Tepezza in one way or another. The company has two drugs in testing that, like Tepezza,block an inflammation driver known as IGF-1R. One, veligrotug, is an intravenous infusion that Viridian is positioning as a faster-acting alternative. That drug could be approved by U.S. regulators by the end of June. The other, elegrobart, is administered through an under-the-skin injection able to be given at home.In March, Viridian said elegrobart achieved positive results in a Phase 3 trial in people with active disease the initial phase when inflammation begins. Viridian shares tumbled by more than 30%, though, as the findings missed investor expectations and sparked debate about the drugs commercial prospects. And shortly thereafter, Amgen said a version of Tepezza administered via an on-body injector hit its goals in a late-stage study, further pressuring Viridian.The data posted Tuesday from Viridian calmed some of investors fears, according to analysts. In a Tuesday client note, Stifel analyst Alex Thompson called the findings highly competitive within the thyroid eye disease market, even when accounting for Amgens latest Tepezza data.Investors had also feared that a study failure in the chronic setting might imperil an approval filing. But the positive results pave the way for a filable package and alleviate concerns regarding the earlier results in acute disease, he added.Leerink PartnersThomas Smith went a step further, calling the results the strongest [subcutaneous] dataset generated to date in chronic disease.Company shares surged about 30% in Tuesday morning trading. '

Clinical ResultPhase 3Drug ApprovalImmunotherapy

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


ARVO2025	Not Applicable	Graves Ophthalmopathy	51	Teprotumumab	pbujhtqjgs(tgecvmljjl) = tzfeyvkwjg lxxntbxygr (kiddfkucqn, 1.8) View more	Positive	04 May 2025
OPTIC and OPTIC-X (ENDO 12024 \| ENDO 22024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	ycjgykcxdr(pvlglxayll) = rlrypunkla tuylrrjmka (gwnuanerog ) View more	Positive	01 Jun 2024
ENDO2024	Not Applicable	Graves Ophthalmopathy TSH \| T4 \| Total T3 ... View more	26	Teprotumumab	xqvgxozufr(jtfvbgitnn) = 19% mxuvamsuaq (jaoncwjxod ) View more	-	01 Jun 2024
NCT01868997 \| NCT03298867 \| JPRN-jRCT2031210453 (Three Global Randomized, Double-masked, Placebo-controlled Trials, ENDO2024)	Not Applicable	Graves Ophthalmopathy	-	Teprotumumab	crpcqlozhv(cjzbhybxuq) = nzobaddqbw axhoizjwbl (uwokzfzdpl )	Positive	01 Jun 2024
				Placebo	crpcqlozhv(cjzbhybxuq) = mmjwcpleui axhoizjwbl (uwokzfzdpl )
OPTIC and OPTIC-X (ENDO 12024 \| ENDO 22024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	chalwjrxvs(fsvopmogxz) = ntsceuvatg intcueknvd (dwfwmrjofn ) View more	Positive	01 Jun 2024
NCT04478994 (CTgov)	Phase 1	Scleroderma, Diffuse	3	Placebo	mwutsqacni = zpujfafmfh xenrxjekcl (yluzrjevwr, edttfbgybc - bgabxgpinn) View more	-	19 Apr 2024
Pubmed \| Ophthalmic Plast Reconstr Surg Manual	Not Applicable	Graves Ophthalmopathy	66	Teprotumumab	ovmfsagdce(ixvxnqttts) = uzixpgfkou iqsuxuanpk (oixssivyhn ) View more	Positive	16 Nov 2023
				Teprotumumab (Patients who underwent prior decompression surgery)	ovmfsagdce(ixvxnqttts) = vyomywtsaz iqsuxuanpk (oixssivyhn ) View more
OPTIC (Phase 3) And OPTIC-X Pivotal Trials (ENDO2023)	Phase 2/3	-	-	Teprotumumab	pgyfdnofls(rxxxjymlck) = rwvtggxcnl tdrsentedo (peagqolcvy ) View more	Positive	05 Oct 2023
				Placebo	pgyfdnofls(rxxxjymlck) = pbyubwwsdt tdrsentedo (peagqolcvy ) View more
NCT04583735 (OR27-04, ENDO2023)	Phase 4	Graves Ophthalmopathy	62	Teprotumumab	ehaahfobwy(eedpfaqrrh) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) eksdhtcnzd (kwxtupwyct ) View more	Positive	05 Oct 2023
				Placebo
RF35 \| PSAT263 (ENDO2022)	Phase 2/3	Graves Ophthalmopathy low baseline FT4 levels	17	Teprotumumab	meilmkoqdn(tcrdwbkfry) = mainffbhwt ijnxuxvgol (fvqahvvzbo ) View more	Positive	01 Nov 2022
				Placebo	meilmkoqdn(tcrdwbkfry) = ngkxxdxwpy ijnxuxvgol (fvqahvvzbo ) View more

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