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The largest new wave of TED drugs targets the autoimmune cause it shares with Graves’ disease
Thyroid eye disease (TED) drug development has moved upstream: the biggest group of new programs now aims at the autoimmune root that drives both TED and Graves’ disease, rather than at the eye. Sleuth’s June 2026 map of 91 TED and Graves’ assets places 44 in this next-generation upstream wave, against 22 legacy IGF-1R programs and 13 repurposed antibodies.
The bet behind the shift is that one drug could treat both conditions, possibly before TED ever develops, which makes the prize larger than a better version of Amgen’s Tepezza (teprotumumab).
Three waves, sorted by where each drug acts
The 79 assets in the three waves are sorted by where they intervene: orbital tissue (the symptom), inflammatory signaling, or the autoimmune root (the cause).
- Wave 1, legacy IGF-1R (22 assets): all block IGF-1R at the orbit, the target Tepezza validated, and only 9% pursue both TED and Graves’. Companies include Amgen, Viridian, Sanofi, Astellas, Innovent, Roche and Xencor.
- Wave 2, repurposed antibodies (13): FcRn and anti-inflammatory antibodies borrowed from other autoimmune diseases, eight acting on inflammatory signaling and five on the autoimmune root. 31% pursue both diseases. Companies include argenx, CSL, Novartis, Roche, Pfizer, Immunovant, CSPC and Hengrui.
- Wave 3, next-generation upstream (44): 41 of the 44 (93%) act on the autoimmune root, mostly the TSH receptor (TSHR) that drives both conditions, and 55% pursue both diseases. Companies include Ethyreal Bio, Septerna, Viridian, Crinetics, Regeneron, Lundbeck, Lycia, Merida Biosciences, Velavigo, Biohaven and Enliven.
The further upstream a program acts, the more likely it is built for Graves’ and TED together, from 9% in Wave 1 to 55% in Wave 3. FcRn’s move across antibody-driven diseases is covered in Sleuth’s I&I Intelligence Report, Q3 2026.
The upstream wave is early and mostly outside big pharma
Wave 3 is the largest class but the least mature. About 66% of its programs are preclinical, none is past Phase 2, and only 2 of the 44 have any big pharma involvement. Capital is still arriving: Ethyreal Bio launched on June 10, 2026 with $101 million to take ETHY-001, a TSHR antibody for both Graves’ and TED, into the clinic by the end of 2026.
In Sleuth’s view, BD activity in this wave is likely to pick up over the following 18 months as the first clinical data on TSHR-directed assets arrive. After this analysis, on August 31, 2026, Eli Lilly agreed to acquire Merida Biosciences, one of the Wave 3 developers, for up to about $2.9 billion including milestones; Merida’s lead drug, MER511, is in Phase 1 for Graves’ disease.
The prize is disease modification in Graves’, not a better Tepezza
Tepezza is the benchmark the field is trying to beat. Amgen reported $1.9 billion in Tepezza sales for 2025. Sleuth estimates the core TED opportunity is closer to $5 billion, with about 80% of moderate-to-severe patients still untreated.
Tepezza works, but its profile leaves room: eight IV infusions over about six months, a treatment course of roughly $500,000, and a hearing impairment signal. Hearing symptoms were reported in about 10% of patients in trials, while some small real-world studies have reported otologic symptoms in roughly 65% to 81% of patients. The signal carries an FDA label warning and has drawn litigation against Amgen. Nearly every emerging program is subcutaneous or oral, and mechanisms with lower hearing risk are positioning for earlier-line or combination use.
After this analysis, on June 26, 2026, the FDA approved Viridian’s veligrotug as Lumvoa for TED regardless of disease activity or duration. It is a Wave 1 IGF-1R antibody given as five IV infusions over 12 weeks.
A shorter IGF-1R course improves on Tepezza within the same mechanism. The larger prize Wave 3 is chasing is the first disease-modifying therapy for Graves’ itself.
Asset counts, wave assignments and shares are as of June 2026. Of the 91 assets mapped, 79 fall into the three waves. Market size and untreated share are Sleuth estimates. The Ethyreal Bio launch, Tepezza’s 2025 sales, the Lumvoa approval and the Lilly and Merida deal were checked in September 2026. This page is a dated snapshot.
Frequently asked questions about the TED and Graves’ disease pipeline
What are the three waves of TED drug development?
In Sleuth’s June 2026 map, Wave 1 is 22 legacy IGF-1R programs that act at the orbit, Wave 2 is 13 repurposed FcRn and anti-inflammatory antibodies, and Wave 3 is 44 next-generation programs that act upstream, mostly on the TSH receptor.
How many TED and Graves’ programs target the autoimmune root?
As of June 2026, 41 of the 44 Wave 3 programs and 5 of the 13 Wave 2 antibodies act on the autoimmune root rather than the eye. About 66% of Wave 3 is preclinical and none is past Phase 2.
Which drugs are approved for thyroid eye disease?
Amgen’s Tepezza (teprotumumab), an IGF-1R antibody, had 2025 sales of $1.9 billion. On June 26, 2026, the FDA also approved Viridian’s veligrotug (Lumvoa), another IGF-1R antibody, given as five IV infusions over 12 weeks.
