Lumvoa (veligrotug)

The second IGF-1R antibody approved for TED, after teprotumumab (Tepezza) in January 2020. Lumvoa is given as 5 infusions of 10 mg/kg over 12 weeks, while Tepezza is given as 8 infusions (10 mg/kg, then 20 mg/kg) every 3 weeks. Both labels carry hearing warnings, and the 2 drugs have not been compared head-to-head.

In thyroid eye disease (TED), the immune system switches on cells behind the eye called orbital fibroblasts, which carry a receptor called IGF-1R. Signals through that receptor help drive the growth of fat and muscle inside the bony eye socket, which pushes the eye forward (proptosis) and can pull the eyes out of line, causing double vision. Veligrotug is a lab-made antibody that attaches to IGF-1R and blocks it from being switched on. The label notes that its mechanism in TED has not been fully characterized. In the trials, eye bulging began to improve as early as 3 weeks after the first infusion.

Lumvoa has no boxed warning and no contraindications. In the 2 main trials, the most common side effects against placebo were muscle spasms (40% against 7%), headache (17% against 14%), hearing problems such as ringing, muffled hearing or hearing loss (15% against 6%), high blood sugar (13% against 5%), fatigue (13% against 11%), diarrhea (11% against 7%), ear discomfort such as a plugged feeling (10% against 3%), infusion reactions (9% against 2%), nausea (8% against 6%) and cold-like symptoms (7% against 1%). Menstrual changes such as missed or irregular periods were reported in about 29% of menstruating women on Lumvoa against 6% on placebo. The label warns that it may cause severe hearing loss that in some cases may be permanent, so hearing should be checked before, during and after treatment. It can also worsen inflammatory bowel disease, raise blood sugar (in 12% of trial patients, half of whom already had diabetes or impaired glucose tolerance) and harm an unborn baby, so women who could become pregnant need a pregnancy test before starting and effective birth control until 6 months after the last dose^[1].

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Approval rested on 2 randomized, double-masked, placebo-controlled Phase 3 trials with 301 patients in total, randomized 2 to 1 to veligrotug or placebo. THRIVE (NCT05176639) enrolled 113 people with active TED (onset within 15 months and a clinical activity score of 3 or more). At week 15, 70% on veligrotug had eye bulging reduced by at least 2 mm, against 5% on placebo, and bulging fell by 2.9 mm on average against 0.5 mm. THRIVE-2 (NCT06021054) enrolled 188 people with chronic TED (onset more than 15 months earlier, any activity score); the responder rates were 57% against 8%, with bulging down 2.4 mm against 0.5 mm. Among people with double vision at the start, it went away completely in 49% against 12% in THRIVE and 32% against 14% in THRIVE-2. Of the people whose bulging responded by week 15, 71% in THRIVE and 57% in THRIVE-2 still met that response at week 52^[1].

Viridian Therapeutics developed veligrotug under the code VRDN-001. THRIVE reported positive topline results on September 10, 2024 and THRIVE-2 on December 16, 2024^[5][6]. The FDA granted Breakthrough Therapy designation in May 2025, received the application on October 31, 2025, and gave it Priority Review with a target date of June 30, 2026^[7][2]. The FDA approved Lumvoa on June 26, 2026, and Viridian launched it right away as its first commercial product^[2][3][4]. Viridian is also developing elegrobart (formerly VRDN-003), an under-the-skin injection with the same binding domain, which reported positive Phase 3 results in active TED in March 2026; Viridian plans to file for approval in the first quarter of 2027^[8][4].

For decades TED was treated with steroids during the active phase and surgery afterward. It now has 2 approved IGF-1R antibodies, Tepezza and Lumvoa, both given by IV infusion. Viridian's under-the-skin injection elegrobart reported positive Phase 3 results in 2026 and is headed for an FDA filing in early 2027, and an oral IGF-1R blocker, linsitinib, is in a Phase 3 trial.