BHV-1600
An investigational treatment for Peripartum Cardiomyopathy.
The same compound appears under different names depending on the context. Here is how to identify BHV-1600 wherever you encounter it, plus the key facts at a glance.
- Generic name
- BHV-1600
- Development codes
- BHV-1600, BHV1600
- Drug class
- Targeted autoantibody degrader (TRAP subtype of MoDE)
- Manufacturer
- Biohaven
- How it's taken
- Given as a subcutaneous (under-the-skin) injection.
An investigational subcutaneous autoantibody degrader from Biohaven designed to selectively remove pathogenic beta-1 adrenergic receptor (β1-AR) autoantibodies implicated in peripartum cardiomyopathy (PPCM), a rare, life-threatening form of heart failure that develops during or shortly after pregnancy. BHV-1600 entered Phase 1 in healthy volunteers in late 2024, and Biohaven held an FDA INTERACT meeting aligning on an accelerated-approval development pathway before initiating a patient study[2][3].
How BHV-1600 works
Peripartum cardiomyopathy (PPCM) is a rare, serious form of heart failure that develops in the last month of pregnancy or in the months right after delivery[4]. In many women with PPCM, the immune system makes an antibody that attacks a switch on heart cells called the beta-1 adrenergic receptor (β1-AR).
That receptor normally tells the heart how hard and how fast to pump when the body needs more oxygen. When the autoantibody locks onto it, it interferes with that signal and injures heart muscle cells, which is one reason the heart becomes weaker and can't pump as well[2]. BHV-1600 is built to remove that bad antibody.
Using Biohaven's TRAP (Targeted Removal of Aberrant Proteins) technology, the molecule grabs the β1-AR autoantibody specifically and ferries it to the liver, where it's broken down. Because TRAP targets only the disease-causing antibody and leaves the rest of the immune system's antibodies intact, the approach is designed to calm the heart without broadly weakening defenses against infection[3].
Mechanism: TRAP (Targeted Removal of Aberrant Proteins) degrader that selectively removes pathogenic beta-1 adrenergic receptor autoantibodies from the circulation
Side effects and safety
Phase 1 safety data in healthy volunteers have not shown major red flags through single- and multiple-ascending-dose cohorts, with typical injection-site reactions and generally mild lab changes, per Biohaven's public updates[3]. Because BHV-1600 is selective for β1-AR autoantibodies and does not broadly lower IgG, the infection risk profile is expected to differ from pan-IgG-lowering drugs, but this must be confirmed in patient studies. Safety in pregnant or postpartum women will be studied carefully once patient dosing begins, given the unique clinical setting of PPCM.
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-1600
Given as a subcutaneous (under-the-skin) injection. Exact dosing and frequency for the patient program have not been disclosed publicly; the Phase 1 healthy-volunteer program used a typical single- and multiple-ascending-dose schedule[3].
Clinical trial results
Biohaven began Phase 1 studies of BHV-1600 in healthy volunteers in the fourth quarter of 2024, and its 2025 annual report says early results from the first 2 dose cohorts showed it was safe and well tolerated, with no serious adverse events[1]. In Q4 2024, the company held an FDA INTERACT meeting and reported alignment on an accelerated-approval pathway for PPCM based on biomarker reduction of circulating β1-AR autoantibodies together with cardiac imaging and functional endpoints[2]. The patient study has not yet posted publicly under a disclosed NCT identifier as of early 2026; check ClinicalTrials.gov and Biohaven's pipeline page for the most current status[3].
Development history
PPCM has no FDA-approved disease-specific therapy. Standard care follows general heart failure guidelines (beta-blockers, ACE inhibitors or ARNI after delivery, diuretics, anticoagulation when indicated) and bromocriptine has been studied in Europe, but outcomes remain poor for a subset of women who do not recover cardiac function[4]. Biohaven selected PPCM as a lead TRAP indication because β1-AR autoantibodies are a well-characterized, disease-specific target, and because the unmet need and rapid biomarker readout support a potential accelerated-approval path[2].
Explore Peripartum Cardiomyopathy trials
Common questions about BHV-1600
▸What is BHV-1600?
An investigational subcutaneous autoantibody degrader from Biohaven designed to selectively remove pathogenic beta-1 adrenergic receptor (β1-AR) autoantibodies implicated in peripartum cardiomyopathy (PPCM), a rare, life-threatening form of heart failure that develops during or shortly after pregnancy. BHV-1600 entered Phase 1 in healthy volunteers in late 2024, and Biohaven held an FDA INTERACT meeting aligning on an accelerated-approval development pathway before initiating a patient study[2][3].
▸How does BHV-1600 work?
Peripartum cardiomyopathy (PPCM) is a rare, serious form of heart failure that develops in the last month of pregnancy or in the months right after delivery[4]. In many women with PPCM, the immune system makes an antibody that attacks a switch on heart cells called the beta-1 adrenergic receptor (β1-AR).
That receptor normally tells the heart how hard and how fast to pump when the body needs more oxygen. When the autoantibody locks onto it, it interferes with that signal and injures heart muscle cells, which is one reason the heart becomes weaker and can't pump as well[2]. BHV-1600 is built to remove that bad antibody.
Using Biohaven's TRAP (Targeted Removal of Aberrant Proteins) technology, the molecule grabs the β1-AR autoantibody specifically and ferries it to the liver, where it's broken down. Because TRAP targets only the disease-causing antibody and leaves the rest of the immune system's antibodies intact, the approach is designed to calm the heart without broadly weakening defenses against infection[3].
▸What are the side effects of BHV-1600?
Phase 1 safety data in healthy volunteers have not shown major red flags through single- and multiple-ascending-dose cohorts, with typical injection-site reactions and generally mild lab changes, per Biohaven's public updates[3]. Because BHV-1600 is selective for β1-AR autoantibodies and does not broadly lower IgG, the infection risk profile is expected to differ from pan-IgG-lowering drugs, but this must be confirmed in patient studies. Safety in pregnant or postpartum women will be studied carefully once patient dosing begins, given the unique clinical setting of PPCM.
▸How is BHV-1600 taken?
Given as a subcutaneous (under-the-skin) injection. Exact dosing and frequency for the patient program have not been disclosed publicly; the Phase 1 healthy-volunteer program used a typical single- and multiple-ascending-dose schedule[3].
▸Is BHV-1600 FDA approved?
BHV-1600 is currently in phase 1 clinical trials for Peripartum Cardiomyopathy. It has not yet received FDA approval.
▸How is BHV-1600 different from BHV-1300?
BHV-1300 is a broad IgG degrader — it lowers total IgG antibodies, including the thyroid-stimulating antibodies in Graves' disease. BHV-1600 is a TRAP (Targeted Removal of Aberrant Proteins) degrader — it is selective for one specific autoantibody (anti-β1 adrenergic receptor) and leaves the rest of the IgG pool largely intact. That selectivity is why Biohaven chose TRAP for PPCM: the goal is to remove only the pathogenic antibody without suppressing overall immunity in young postpartum women[2].
▸When will BHV-1600 be available for PPCM patients?
Not for several years at the earliest. Phase 1 healthy-volunteer cohorts are complete and the FDA has aligned on an accelerated-approval pathway, but patient dosing, pivotal trials, and regulatory review are still ahead. Women with PPCM should continue standard heart-failure management with their cardiologist and can ask about clinical-trial referrals as studies open[4][2].
▸Is PPCM treatable with existing drugs?
Yes — many women recover cardiac function with standard heart-failure therapy (beta-blockers, ACE inhibitors/ARBs or ARNI after delivery, diuretics, and anticoagulation when the ejection fraction is very low). However, a meaningful minority do not fully recover, and there is no therapy that targets the underlying autoimmune attack on the heart. That's the gap BHV-1600 is aimed at[4].
▸Why is a rare postpartum disease a priority for a small biotech?
PPCM affects roughly 1 in 1,000 to 1 in 4,000 U.S. pregnancies, and is much more common in women of African descent. Despite being rare, it carries high short- and long-term mortality and has no approved disease-specific therapy. A targeted biologic with a clear biomarker (β1-AR autoantibody level) and a defined patient population is exactly the setting where accelerated-approval pathways are designed to reward innovation[2].
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.
- U.S. Securities and Exchange Commission · 2026-03. Biohaven Ltd. Annual Report on Form 10-K for fiscal year 2025. https://www.sec.gov/Archives/edgar/data/1935979/000193597926000020/bhvn-20251231.htm
- Biohaven (Investor Relations) · Q4 2024. Biohaven Announces FDA INTERACT Meeting Alignment on Accelerated Approval Pathway for BHV-1600 in Peripartum Cardiomyopathy. https://ir.biohaven.com/news-releases/news-release-details/biohaven-reports-recent-business-developments-and-fourth-quarter
- Biohaven · 2025. Biohaven Pipeline — BHV-1600 Peripartum Cardiomyopathy Program. https://www.biohaven.com/pipeline/
- American Heart Association / Journal of the American College of Cardiology. Peripartum Cardiomyopathy: Diagnosis and Management. https://www.heart.org/en/health-topics/cardiomyopathy/what-is-cardiomyopathy-in-adults/peripartum-cardiomyopathy-ppcm