BHV-1300
An investigational treatment for Graves' Disease.
The same compound appears under different names depending on the context. Here is how to identify BHV-1300 wherever you encounter it, plus the key facts at a glance.
- Generic name
- BHV-1300
- Development codes
- BHV-1300, BHV1300
- Drug class
- Extracellular protein degrader (MoDE)
- Manufacturer
- Biohaven
- How it's taken
- Given as an injection under the skin once a week.
BHV-1300 is an investigational weekly injection under the skin from Biohaven for Graves' disease, the first extracellular protein degrader to reach a Phase 3 trial. It removes the IgG antibodies that overstimulate the thyroid instead of blocking hormone production or destroying the gland. As of October 1, 2026 it is in a Phase 3 trial (NCT07661056) that began enrolling in June 2026 in about 300 adults, with the primary result due after January 2028. In the first Graves' patient treated, reported in January 2026, the disease-driving TSH receptor antibodies (TRAb) became undetectable and thyroid hormones normalized within weeks; across the first 3 patients, reported in June 2026, weekly 1,000 mg doses removed more than 80% of TRAb and normalized free T4 and free T3. In Phase 1, total IgG fell by up to 87% from baseline. It is not FDA-approved and is available only in trials[1][4][2].
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How BHV-1300 works
Graves' disease happens when the immune system makes an antibody that acts like a stuck gas pedal for the thyroid gland. Normally the thyroid is told how much hormone to make by a brain signal called TSH. In Graves' disease, the body mistakenly makes an antibody (called a TSH receptor antibody, or TRAb) that locks onto the same switch as TSH and keeps it turned on, so the thyroid keeps pumping out hormone no matter what.
That is what causes the rapid heartbeat, weight loss, tremor, heat intolerance and eye problems people with Graves' feel[8]. BHV-1300 is designed to remove that antibody from the blood. It is built on Biohaven's MoDE (Molecular Degrader of Extracellular proteins) platform: one end of the molecule grabs IgG antibodies floating in the blood, and the other end sticks to a protein on the surface of liver cells called ASGPR.
The liver pulls the attached IgG inside and breaks it down. Because TRAb is an IgG antibody, lowering IgG lowers TRAb too, which takes the pressure off the thyroid and lets hormone levels return to normal. Biohaven reports that the drug spares IgG3, IgA, IgM and IgE, the antibody types it does not target[4][6].
Mechanism: IgG-selective extracellular protein degrader (MoDE platform) that tags circulating IgG antibodies, including the TSH receptor autoantibodies that drive Graves' disease, for rapid clearance by the liver
Side effects and safety
In the Phase 1 healthy-volunteer study, BHV-1300 was generally well tolerated across single and multiple doses up to 1,000 mg weekly. Most side effects were mild and included injection site reactions, headache, and passing lab changes in fibrinogen and albumin that were not linked to bleeding or other problems. Immunoglobulin levels returned toward normal after dosing stopped, and no serious infections were reported[6].
Biohaven says nearly 200 people have been dosed with its MoDE and TRAP degraders in Phase 1 testing, with most adverse events mild and self-resolving[4]. Because the drug lowers IgG, which includes antibodies that fight infection, the Phase 3 trial is tracking infection risk with repeated dosing over 26 weeks and beyond.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking BHV-1300
Given as an injection under the skin once a week. In the Phase 3 trial it is delivered with an autoinjector, which Biohaven says is designed for patients to use at home. In Phase 1 testing, weekly doses up to 1,000 mg produced about 80% median IgG reduction, with maximum reductions of up to 87% from baseline[6][1][2].
Clinical trial results
Three studies matter. The Phase 1 healthy-volunteer study, which Biohaven has reported in press releases rather than a public trial registration, tested single and multiple doses in more than 100 adults and showed dose-dependent, deep IgG reduction with a clean safety profile[6]. An open-label Phase 1 study in adults with Graves' disease (NCT06980649, 15 people planned, recruiting as of October 2026) produced the first patient data. Biohaven reported on January 12, 2026 that the first patient dosed had complete suppression of TRAb with normalization of thyroid hormones within weeks, and on June 29, 2026 that across the first 3 patients weekly 1,000 mg doses removed more than 80% of TRAb, normalized free T4 and free T3 and improved symptoms, with IgG3, IgA, IgM and IgE spared[1][5][4]. The pivotal Phase 3 trial (NCT07661056) enrolled its first patient in June 2026, as Biohaven announced on June 29, 2026: a randomized, double-blind, placebo-controlled study in about 300 adults aged 18 to 70 with active hyperthyroidism from Graves' disease, assigned 2 to 1 to BHV-1300 or placebo by autoinjector. The primary endpoint is the number of people off antithyroid drugs with normal T3, free T4 and TSH at week 26. Primary completion is estimated for January 2028[2][4].
Main registered trial: NCT07661056 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Development history
BHV-1300 is the lead program in Biohaven's MoDE platform, licensed from Professor David Spiegel's group at Yale and built in parallel with the TRAP (Targeted Removal of Aberrant Proteins) subtype used for BHV-1400[7]. Biohaven chose a broad IgG-lowering design because many autoimmune diseases, including Graves' disease, myasthenia gravis and warm autoimmune hemolytic anemia, are driven by IgG antibodies. The first healthy-volunteer study began in 2023. Graves' disease became the first patient indication because TRAb levels track closely with disease activity, giving an early, measurable readout. Biohaven reported the first patient's result on January 12, 2026, fuller biomarker data on May 27, 2026, and started the Phase 3 trial a month after that, calling it the first extracellular degrader to reach a pivotal trial[5][4]. On October 8, 2026, Biohaven licensed BHV-1300 and its follow-on IgG degraders BHV-1310 and BHV-1320 to Ono Pharmaceutical for Japan, South Korea, Taiwan and Southeast Asia, for $80 million upfront, a further $20 million milestone Biohaven expects within a year, and royalties of about 20% on Ono's sales there. Biohaven kept all rights in the US, Europe and China[3].
Explore Graves' Disease trials
Common questions about BHV-1300
▸What is BHV-1300?
BHV-1300 is an investigational weekly injection under the skin from Biohaven for Graves' disease, the first extracellular protein degrader to reach a Phase 3 trial. It removes the IgG antibodies that overstimulate the thyroid instead of blocking hormone production or destroying the gland. As of October 1, 2026 it is in a Phase 3 trial (NCT07661056) that began enrolling in June 2026 in about 300 adults, with the primary result due after January 2028. In the first Graves' patient treated, reported in January 2026, the disease-driving TSH receptor antibodies (TRAb) became undetectable and thyroid hormones normalized within weeks; across the first 3 patients, reported in June 2026, weekly 1,000 mg doses removed more than 80% of TRAb and normalized free T4 and free T3. In Phase 1, total IgG fell by up to 87% from baseline. It is not FDA-approved and is available only in trials[1][4][2].
▸How does BHV-1300 work?
Graves' disease happens when the immune system makes an antibody that acts like a stuck gas pedal for the thyroid gland. Normally the thyroid is told how much hormone to make by a brain signal called TSH. In Graves' disease, the body mistakenly makes an antibody (called a TSH receptor antibody, or TRAb) that locks onto the same switch as TSH and keeps it turned on, so the thyroid keeps pumping out hormone no matter what.
That is what causes the rapid heartbeat, weight loss, tremor, heat intolerance and eye problems people with Graves' feel[8]. BHV-1300 is designed to remove that antibody from the blood. It is built on Biohaven's MoDE (Molecular Degrader of Extracellular proteins) platform: one end of the molecule grabs IgG antibodies floating in the blood, and the other end sticks to a protein on the surface of liver cells called ASGPR.
The liver pulls the attached IgG inside and breaks it down. Because TRAb is an IgG antibody, lowering IgG lowers TRAb too, which takes the pressure off the thyroid and lets hormone levels return to normal. Biohaven reports that the drug spares IgG3, IgA, IgM and IgE, the antibody types it does not target[4][6].
▸What are the side effects of BHV-1300?
In the Phase 1 healthy-volunteer study, BHV-1300 was generally well tolerated across single and multiple doses up to 1,000 mg weekly. Most side effects were mild and included injection site reactions, headache, and passing lab changes in fibrinogen and albumin that were not linked to bleeding or other problems. Immunoglobulin levels returned toward normal after dosing stopped, and no serious infections were reported[6].
Biohaven says nearly 200 people have been dosed with its MoDE and TRAP degraders in Phase 1 testing, with most adverse events mild and self-resolving[4]. Because the drug lowers IgG, which includes antibodies that fight infection, the Phase 3 trial is tracking infection risk with repeated dosing over 26 weeks and beyond.
▸How is BHV-1300 taken?
Given as an injection under the skin once a week. In the Phase 3 trial it is delivered with an autoinjector, which Biohaven says is designed for patients to use at home. In Phase 1 testing, weekly doses up to 1,000 mg produced about 80% median IgG reduction, with maximum reductions of up to 87% from baseline[6][1][2].
▸Is BHV-1300 FDA approved?
BHV-1300 is currently in phase 3 clinical trials for Graves' Disease. It has not yet received FDA approval.
▸What is BHV-1300?
BHV-1300 is an investigational Graves' disease drug from Biohaven, given as a weekly injection under the skin. It is an extracellular protein degrader: it attaches to IgG antibodies in the blood, including the TSH receptor antibodies that cause Graves' disease, and sends them to the liver to be destroyed. It is in a Phase 3 trial and is not FDA-approved[4].
▸What phase is BHV-1300 in?
▸What did BHV-1300 show in Graves' disease patients?
In the first patient dosed, reported January 12, 2026, TSH receptor antibodies (TRAb) became undetectable and thyroid hormones normalized within weeks. In preliminary data from the first 3 patients, reported June 29, 2026, weekly 1,000 mg doses removed more than 80% of TRAb, normalized free T4 and free T3, and improved hallmark symptoms, while sparing IgG3, IgA, IgM and IgE. These are early results in a handful of people, not a controlled trial[1][4].
▸How is BHV-1300 given?
▸When could BHV-1300 be approved?
No date has been announced. The Phase 3 trial's primary completion is estimated for January 2028, and Biohaven would need to file with the FDA after that, so an approval decision before 2029 would be unusual. Trial Friend's FDA calendar will list a decision date once one is public[2].
▸How is BHV-1300 different from FcRn inhibitors like Vyvgart or IMVT-1402?
Both lower IgG, but in different places. FcRn inhibitors such as Vyvgart (efgartigimod) and Immunovant's IMVT-1402 block the recycling of IgG inside cells, so antibodies are cleared faster. BHV-1300 works in the bloodstream itself: it tags IgG and delivers it to liver cells through the ASGPR receptor. In Phase 1, BHV-1300 reached up to 87% maximum IgG reduction with weekly dosing. IMVT-1402 is in Graves' trials registered as Phase 2 as of October 2026; BHV-1300 is in Phase 3[6][2].
▸How do I enroll in the BHV-1300 Graves' disease trial?
The Phase 3 trial is listed on ClinicalTrials.gov as NCT07661056. It is for adults aged 18 to 70 with Graves' disease confirmed by antibody testing and active hyperthyroidism; people who have had radioactive iodine or thyroid surgery, or who took thyroid hormone in the 6 weeks before screening, are excluded. Ask your endocrinologist whether you fit and check the record for a site near you[2].
▸Is BHV-1300 available through expanded access?
Not as of October 2026. BHV-1300 is investigational and only available in its clinical trials. Biohaven has not announced an expanded access program for Graves' disease.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Biohaven (Investor Relations) · 2026-01-12. Biohaven Highlights Portfolio Progress, Positive Early Patient Data from Priority Degrader Programs and Anticipated Milestones at the 44th Annual J.P. Morgan Healthcare Conference. https://ir.biohaven.com/news-releases/news-release-details/biohaven-highlights-portfolio-progress-positive-early-patient
- ClinicalTrials.gov · 2026-10-01. A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease. https://clinicaltrials.gov/study/NCT07661056
- Biohaven · 2026-10-08. Biohaven Enters Strategic Licensing Agreement with Ono Pharma for Extracellular IgG Degraders in Japan and Select Asian Regions, Lead Candidate BHV-1300 in Phase 3 for Graves' Disease. https://ir.biohaven.com/news-releases/news-release-details/biohaven-enters-strategic-licensing-agreement-ono-pharma
- Biohaven via PR Newswire · 2026-06-29. Biohaven Advances a New Class of Precision Immunology Therapies: First MoDE Extracellular Protein Degrader, BHV-1300, Begins Phase 3 Pivotal Trial in Graves' Disease. https://www.prnewswire.com/news-releases/biohaven-advances-a-new-class-of-precision-immunology-therapies-first-mode-extracellular-protein-degrader-bhv-1300-begins-phase-3-pivotal-trial-in-graves-disease-302812720.html
- Biohaven via PR Newswire · 2026-05-27. Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Disease and IgA Nephropathy. https://www.prnewswire.com/news-releases/biohaven-reports-positive-clinical-biomarker-and-patient-data-first-mode-and-trap-extracellular-protein-degraders-achieve-deep-rapid-selective-lowering-of-disease-driving-antibodies-in-graves-disease-and-iga-nephropathy-302783023.html
- Biohaven (Investor Relations) · 2024. Biohaven Reports Positive Degrader Data Achieving 80% Sustained IgG Lowering With BHV-1300. https://ir.biohaven.com/news-releases/news-release-details/biohaven-reports-positive-degrader-data-achieving-80-sustained
- Biohaven (Investor Relations) · 2022. Biohaven Advances Development of MoDE Platform Technology Licensed from Yale. https://ir.biohaven.com/news-releases/news-release-details/biohaven-advances-development-mode-platform-technology-licensed
- Graves' Disease & Thyroid Foundation. Understanding Graves' Disease and TSH Receptor Antibodies. https://www.gdatf.org/about/about-graves-disease/
- American Thyroid Association / Thyroid · 2016. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism. https://pubmed.ncbi.nlm.nih.gov/27521067/