GRAVES’ DISEASE PHASE 3 STUDY
Graves’ disease is more than a thyroid condition – it’s an autoimmune disease that affects nearly 1 in 100 Americans. For more than 70 years, treatment options have barely changed. Biohaven is investigating a different approach designed to address the root cause not just the symptoms.
Who’s Included?
Adults; All genders
18–70
Drug & Formulation
BHV-1300
Auto-injector
Possibility of Placebo
Understanding The Disease
What Happens in Graves’ Disease?
Graves’ disease is an autoimmune disorder in which your immune system mistakenly produces antibodies that attack your thyroid gland, causing it to overproduce thyroid hormone. These antibodies — called thyrotropin receptor antibodies (TRAb) — are the root cause of the disease and can also drive serious complications like thyroid eye disease.
Because the body’s thyroid hormones regulate nearly every organ system, excess levels lead to a wide range of symptoms that can affect your heart, eyes, muscles, mood and more.
- Racing heartbeat or palpitations
- Unintended weight loss
- Eye inflammation or bulging
- Anxiety, irritability or mood changes
- Heat intolerance and sweating
- Muscle weakness and tremors
- Trouble sleeping
- Skin changes on legs or shins
The Treatment Landscape
Current Treatments Have Real Limitations
Despite how common Graves’ disease is, available treatments have not meaningfully changed in over 70 years. They work by managing symptoms — not by addressing the underlying autoimmune cause. That means many people continue to live with disease activity and related complications.
Current options — including antithyroid drugs like methimazole and PTU, radioactive iodine and surgery — focus on managing symptoms or removing the thyroid altogether, but none of them address the underlying antibodies that actually drive the disease. Many people continue to live with ongoing disease activity, and these treatments carry real risks, including liver failure, permanent hypothyroidism and surgical complications.
A New Approach is Being Studied
Researchers are now exploring a fundamentally different approach: directly targeting the TRAb autoantibodies at the root of Graves’ disease, with the goal of restoring natural thyroid balance, preserving the gland and offering patients a potential path to long-term remission.
Biohaven is researching BHV-1300, an investigational drug designed to address the root cause of Graves’ disease. Learn more about the study.
Study Criteria
Study BHV1300-302 is enrolling adults with active Graves’ disease. The information below gives a general overview — a member of the study team will determine your full eligibility during a screening visit. You maybe be eligible if you meet the criteria below.
- Be an adult (18 or older)
- Have a confirmed Graves’ disease diagnosis with elevated TRAb antibodies
- Have active hyperthyroidism (elevated thyroid hormone levels)
- May or may not currently be on antithyroid drugs
- Be willing to attend regular study clinic visits
- Be able to self administer an injection
- Have previously had thyroid surgery or radioactive iodine treatment
- Be pregnant or breastfeeding
- Have certain active infections or immune conditions
- Be currently taking certain medications that may interact with the study drug
- Have significant liver, kidney or cardiac disease
Learn more about the benefits of joining our trial and see if you qualify today!
Need help talking about Graves’ disease?
Whether it’s with a loved one or your doctor, talking about Graves’ disease can be difficult. Click below to download Biohaven’s Graves’ disease patient conversation guide.
PDF | 5 MB