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Endocrine & Hormonal

Graves’ Disease Clinical Trials and Treatments

Also called Graves disease, Basedow disease, diffuse toxic goiter, autoimmune hyperthyroidism, Graves Disease

Graves' disease is an organ-specific autoimmune disorder caused by thyroid-stimulating antibodies (TSAb) that bind to and activate the TSH receptor on thyroid follicular cells, causing unregulated thyroid hormone production. The resulting hyperthyroidism affects virtually every organ system.

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About Graves’ Disease

Graves' disease is an organ-specific autoimmune disorder caused by thyroid-stimulating antibodies (TSAb) that bind to and activate the TSH receptor on thyroid follicular cells, causing unregulated thyroid hormone production. The resulting hyperthyroidism affects virtually every organ system. Cardiovascular effects include tachycardia, atrial fibrillation, and high-output heart failure. Metabolic effects include weight loss, heat intolerance, and increased bone turnover (osteoporosis risk). Neuropsychiatric effects include anxiety, insomnia, and tremor.

Graves' ophthalmopathy (thyroid eye disease) occurs in about 25-50% of patients and involves inflammation and expansion of orbital tissue, causing eye protrusion, double vision, and in severe cases, vision loss. Current treatments include antithyroid medications (methimazole, propylthiouracil), radioactive iodine therapy, and thyroidectomy. Each has significant limitations: medications have high relapse rates, while RAI and surgery result in permanent hypothyroidism. Novel approaches targeting the underlying autoimmune mechanism, including TSH receptor antibody degraders, represent a potential paradigm shift toward disease modification rather than thyroid destruction.

Why is Graves’ Disease on Trial Friend?Graves' disease affects roughly 1 in 200 Americans, far above the threshold used to define a rare disease (fewer than 200,000 people). Trial Friend includes it because its most serious complication, thyroid eye disease, is rare and produced one of the landmark rare-condition drug approvals (Tepezza), and because autoimmune thyroid research overlaps heavily with the rare autoimmune diseases covered here.

Common Symptoms of Graves’ Disease

Recognizing the signs of Graves’ Disease early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Rapid or irregular heartbeat (palpitations)
  • Unexplained weight loss despite increased appetite
  • Tremors in hands and fingers
  • Heat intolerance and increased sweating
  • Bulging eyes (exophthalmos) or eye irritation
  • Anxiety, irritability, and difficulty sleeping

Who Graves’ Disease Affects

Women are 5-10 times more likely to develop Graves' disease than men. Peak onset is between ages 30-50. Strong genetic component with family clustering. Associated with other autoimmune conditions (type 1 diabetes, rheumatoid arthritis, vitiligo). Smoking increases risk, particularly for eye disease. Stress and postpartum period can trigger onset.

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Side Effect Explorer

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Genetic Testing

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Graves’ Disease Resources

Reputable organizations and medical references for learning more about Graves’ Disease, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Graves’ Disease

Use this Graves’ Disease clinical trial finder to see the 22 studies recruiting patients and 3 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for endocrine & hormonal conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

86 active trials worldwide
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RECRUITINGPHASE2Recently updatedNCT07722546

A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old

Intervention: Felzartamab, Placebo

Sponsor: Biogen

In this study, researchers will learn more about the use of felzartamab in participants with Graves' Disease, also known as GD. GD is an autoimmune disease, which means the body's immune system attacks its own healthy cells. In people with GD, the immune system produces abnormal ...

Ages 18 Years – 75 Years8 locations
Started Jul 2026Updated 3 days agoEst. Jan 2028 (~1y 3m)
RECRUITINGNARecently updatedNCT06864351

Prospective Evaluation of OptiThyDose

Intervention: OptiThyDose

Sponsor: University Children's Hospital Basel

The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).

Ages up to 18 Years7 locations
Started Aug 2025Updated 3 days agoEst. May 2028 (~1y 7m)
RECRUITINGPHASE3Recently updatedNCT07661056

Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

Intervention: BHV-1300, Placebo

Sponsor: Biohaven Therapeutics Ltd.

The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid

Ages 18 Years – 70 Years52 locations
Started Jun 2026Updated 4 days agoEst. Jan 2028 (~1y 3m)
RECRUITINGPHASE2Recently updatedNCT06984627

A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease

Intervention: Rilzabrutinib dose 1, Rilzabrutinib dose 2

Sponsor: Sanofi

This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.

Study details include:

Ages 18 Years – 75 Years24 locations
Started Sep 2025Updated 4 days agoEst. Feb 2027 (~4 months)
RECRUITINGPHASE1Recently updatedNCT07305818

NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease

Intervention: MER511 (IV), Placebo comparator (IV), MER511 (SC), Placebo comparator (SC), MER511 (SC) for MAD, Placebo comparator (SC) for MAD

Sponsor: Merida Biosciences

The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).

Ages 18 Years – 65 Years16 locations
Started Dec 2025Updated 5 days agoEst. Jul 2028 (~1y 9m)
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Active trial locations142 cities in the US
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Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Patient Communities

Connect with other Graves’ Disease patients, caregivers, and advocacy groups across Facebook groups, Reddit communities, and YouTube channels. These patient communities offer peer support, shared experiences, caregiver resources, and real-time discussion about Graves’ Disease treatments, clinical trial participation, and day-to-day disease management.

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Related Endocrine & Hormonal Conditions

Other rare diseases in the endocrine & hormonal category. Patients with Graves’ Disease may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Companies Developing Graves’ Disease Treatments

5 pharmaceutical companies have Graves’ Disease in their rare disease portfolio

Frequently Asked Questions About Graves’ Disease