BHV-1400
An investigational treatment for IgA Nephropathy.
The same compound appears under different names depending on the context. Here is how to identify BHV-1400 wherever you encounter it, plus the key facts at a glance.
- Generic name
- BHV-1400
- Development codes
- BHV-1400, BHV1400
- Drug class
- TRAP degrader (MoDE platform)
- Manufacturer
- Biohaven
- How it's taken
- Given as an injection under the skin (the same way insulin is given).
An investigational first-in-class TRAP degrader from Biohaven that selectively removes galactose-deficient IgA1 (Gd-IgA1), the disease-driving antibody in IgA nephropathy, while leaving normal antibodies intact. In IgA nephropathy patients it cut Gd-IgA1 by more than 60% within 48 hours and about 70% within the first month[1]. The pivotal Phase 3 trial is registered on ClinicalTrials.gov (NCT07642050, about 420 adults aged 18 to 70, 500 mg by autoinjector or placebo in a 2 to 1 split, urine protein at week 52) and was still listed as not yet recruiting when checked on October 6, 2026[3]. Biohaven said in August 2026 that it plans to start the trial in the second half of 2026[4].
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How BHV-1400 works
IgA nephropathy starts when the body makes a faulty version of an antibody called galactose-deficient IgA1 (Gd-IgA1 for short). These faulty antibodies clump together and get stuck in the tiny blood vessels of the kidneys, causing inflammation and scarring that can slowly progress to kidney failure. BHV-1400 is designed to clear those faulty antibodies out of the bloodstream before they can build up.
Each dose grabs onto Gd-IgA1 and carries it to the liver, where the body's normal cleanup system breaks it down, usually within a few hours. What makes BHV-1400 different from other approaches is that it targets only the faulty Gd-IgA1 and leaves your normal, infection-fighting antibodies (IgA, IgG, IgE, IgM) alone.
Biohaven calls this type of medicine a 'TRAP degrader', short for Targeted Removal of Aberrant Protein, and it's part of a broader Biohaven technology called the MoDE platform (Molecular Degraders of Extracellular Proteins). If it reaches approval, BHV-1400 would be the first drug of its kind for IgA nephropathy. Whether it ends up being safer or more effective than the current treatments will depend on the large pivotal trial planned for 2026.
Mechanism: TRAP (Targeted Removal of Aberrant Proteins) degrader that selectively binds galactose-deficient IgA1 (Gd-IgA1) and routes it to hepatic clearance, while sparing normal immunoglobulins (IgA, IgG, IgE, IgM).
Side effects and safety
Because BHV-1400 is still in early clinical trials, the full list of possible side effects hasn't been worked out yet, identifying side effects is one of the main purposes of a Phase 1 study. Biohaven reported at the J.P. Morgan Healthcare Conference in January 2026 that there had been no drug-related side effects in the first IgA nephropathy patients[5]. In its May 27, 2026 update, Biohaven said most side effects in patients had been mild and went away on their own, with no serious or severe side effects, no one stopping the drug and no notable rise in liver tests[1]. More complete safety information will come from the larger pivotal trial starting in 2026.
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-1400
Given as an injection under the skin (the same way insulin is given). In the Phase 1 healthy-volunteer study, Biohaven has reported 2 single-dose levels. The lowest dose tested, 125 mg, dropped the faulty Gd-IgA1 antibody by a median of 60% within 4 hours and by more than 70% at its lowest point, reached by 8 hours, and kept it down for days[2]. A higher 500 mg dose dropped it by up to 81% and kept it low for weeks from a single injection[6].
The final dose, how often it will be given, and whether patients will be able to give themselves the injection at home are still being decided based on the Phase 1 data, the Phase 3 protocol uses a 500 mg dose by autoinjector[3].
How IgA nephropathy treatments compare
As of 2026, five FDA-approved medicines are available for IgA nephropathy, plus active investigational programs. The right choice depends on your proteinuria level, kidney function (eGFR), prior treatments, biopsy findings, and personal preferences around oral pills versus injections. Your nephrologist will help match a treatment to your specific situation. This chart compares the practical differences between options.
5 FDA-approved iga nephropathy treatments are available: Tarpeyo (budesonide (delayed release), approved 2021); Filspari (sparsentan, approved 2023); Fabhalta (iptacopan, approved 2024); Vanrafia (atrasentan, approved 2025); Voyxact (sibeprenlimab, approved 2025); BHV-1400 (BHV-1400, Phase 1). Tarpeyo is typically used as standard corticosteroid considerations apply (immunosuppression, infection risk, glucose changes); first disease-modifying therapy approved specifically for igan.
| Drug | What makes it different | How it works | How it’s given | How often | Where you get it | Safety highlights | FDA approved |
|---|---|---|---|---|---|---|---|
Tarpeyo budesonide (delayed release) | Targets the disease at its source in the gut | Targeted-release corticosteroid that suppresses Gd-IgA1 antibody production in gut-associated lymphoid tissue (Peyer’s patches) | Oral capsule (taken on an empty stomach) | Once daily | Home (specialty pharmacy delivery) | Standard corticosteroid considerations apply (immunosuppression, infection risk, glucose changes); first disease-modifying therapy approved specifically for IgAN | 2021 |
Filspari sparsentan | Dual ETA + AT1 receptor block in one pill (non-immunosuppressive) | Dual endothelin-A and angiotensin-II AT1 receptor antagonist that reduces glomerular pressure and proteinuria | Oral tablet (REMS program) | Once daily | Home (REMS-certified specialty pharmacy) | Boxed warnings for hepatotoxicity and major birth defects; monthly liver enzyme monitoring; confirmed contraception required (pregnancy contraindicated) | 2023 |
Fabhalta iptacopan | First oral complement inhibitor for IgAN | Selective oral inhibitor of complement factor B that blocks alternative-pathway activation driving kidney inflammation | Oral capsule (REMS program) | Twice daily | Home (REMS-certified specialty pharmacy) | Boxed warning for serious encapsulated-bacteria infections; meningococcal, pneumococcal, and Hib vaccinations required at least 2 weeks before starting | 2024 |
Vanrafia atrasentan | Selective ETA blocker, no REMS or routine liver monitoring required | Selective endothelin-A receptor antagonist that reduces glomerular hypertension and fibrosis | Oral tablet (no REMS required) | Once daily | Home (specialty pharmacy delivery) | Boxed warning for major birth defects (pregnancy contraindicated); contraception required during and for 2 weeks after treatment; warnings include hepatotoxicity, fluid retention, and decreased sperm counts | 2025 |
Voyxact sibeprenlimab | First APRIL antagonist; self-injected at home once a month | Monoclonal antibody that blocks APRIL signaling, reducing B-cell production of pathogenic Gd-IgA1 antibodies | Subcutaneous injection (self-administered, no REMS required) | Every 4 weeks | Home (after training from care team) | Routine vaccinations should be up-to-date before starting; live vaccines avoided during treatment; immunoglobulin levels are monitored periodically | 2025 |
BHV-1400 BHV-1400 You are here | Selectively removes only the disease-driving antibody; spares normal immunity | TRAP degrader that selectively binds Gd-IgA1 and routes it to the liver for clearance, sparing normal antibodies | Subcutaneous injection | Phase 1 expansion cohort enrolling IgAN patients; pivotal regimen TBD | Clinical trial site only (not commercially available) | Investigational — Phase 1 healthy-volunteer single-dose data showed up to 81% Gd-IgA1 reduction; spares normal IgA, IgG, IgE, and IgM; pivotal trial planned for 2026 | Phase 1 |
This chart compares FDA-approved IgA nephropathy treatments and one advanced investigational program (BHV-1400). It is not medical advice. All approved IgAN therapies require background renin-angiotensin system (RAS) blockade with an ACE inhibitor or ARB, and many patients also take an SGLT2 inhibitor. Treatment selection should be made with your nephrologist based on your kidney function, biopsy results, proteinuria level, comorbidities, and prior therapies.
Clinical trial results
In the first human study, healthy volunteers got a single injection of BHV-1400 under the skin. The faulty Gd-IgA1 antibody dropped by as much as 81% from its starting level and stayed low for weeks from just one dose[6]. Normal antibodies, the ones that help fight infections, were not significantly affected, which is what the drug was designed to do: remove only the bad form.
The study has now moved into a group of actual IgA nephropathy patients (the 'expansion cohort') and is enrolling in the United States and United Kingdom under trial number NCT07054684[7]. Biohaven met with the FDA in late 2025 to agree on the design of the pivotal trial, which is now registered as NCT07642050: a randomized, double-blind, placebo-controlled Phase 3 study in about 420 adults with biopsy-confirmed IgA nephropathy, 500 mg of BHV-1400 or placebo by autoinjector on top of standard care, with the change in urine protein at week 52 as the primary endpoint. When checked on October 6, 2026 it was still listed as not yet recruiting[3].
That trial will use a protein-in-urine test (specifically, the urine protein-creatinine ratio, or UPCR) as the main measure of whether the drug is working, the same type of measure the FDA has accepted for other recently approved IgA nephropathy drugs, which helps get treatments to market faster[1].
Development history
BHV-1400 is Biohaven's most advanced drug using its TRAP degrader technology, which Biohaven licensed from Yale University[9]. Biohaven shared the first results from healthy-volunteer studies at its investor R&D Day in May 2025[6] and then shared the first results from actual IgA nephropathy patients at the J.P. Morgan Healthcare Conference in January 2026[5]. Dr. Jonathan Barratt, a leading kidney specialist at the University of Leicester in the UK, helps lead the program as a clinical investigator[11].
Explore IgA Nephropathy trials
Other IgA Nephropathy treatments
IgA nephropathy treatment has evolved through distinct mechanistic layers over the past 5 years. Targeted-release budesonide (Tarpeyo) acts on gut-associated lymphoid tissue to reduce Gd-IgA1 production upstream. Endothelin receptor antagonists (Filspari, Vanrafia) and the complement factor B inhibitor Fabhalta address downstream kidney inflammation and immune-complex damage. APRIL antagonists like sibeprenlimab (Voyxact), and, since July 2026, the dual BAFF/APRIL inhibitor Trutakna (atacicept), suppress the B-cell signaling that drives Gd-IgA1 production.
BHV-1400 sits one step further upstream of all of these. Instead of suppressing production or blocking downstream damage, it removes Gd-IgA1 antibodies that have already been produced while leaving normal antibodies intact. Whether this selective-removal approach proves safer or more durable than the existing options will be determined by the pivotal trial planned for 2026.
Where to access BHV-1400
Investigational: available only through clinical trial enrollment
BHV-1400 has not been approved by the FDA and is not available by prescription. The only way for a patient to receive BHV-1400 today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT07054684
Investigator: Jonathan Barratt, MD, PhD · Mayer Professor of Renal Medicine, University of Leicester
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about BHV-1400
▸What is BHV-1400?
An investigational first-in-class TRAP degrader from Biohaven that selectively removes galactose-deficient IgA1 (Gd-IgA1), the disease-driving antibody in IgA nephropathy, while leaving normal antibodies intact. In IgA nephropathy patients it cut Gd-IgA1 by more than 60% within 48 hours and about 70% within the first month[1]. The pivotal Phase 3 trial is registered on ClinicalTrials.gov (NCT07642050, about 420 adults aged 18 to 70, 500 mg by autoinjector or placebo in a 2 to 1 split, urine protein at week 52) and was still listed as not yet recruiting when checked on October 6, 2026[3]. Biohaven said in August 2026 that it plans to start the trial in the second half of 2026[4].
▸How does BHV-1400 work?
IgA nephropathy starts when the body makes a faulty version of an antibody called galactose-deficient IgA1 (Gd-IgA1 for short). These faulty antibodies clump together and get stuck in the tiny blood vessels of the kidneys, causing inflammation and scarring that can slowly progress to kidney failure. BHV-1400 is designed to clear those faulty antibodies out of the bloodstream before they can build up.
Each dose grabs onto Gd-IgA1 and carries it to the liver, where the body's normal cleanup system breaks it down, usually within a few hours. What makes BHV-1400 different from other approaches is that it targets only the faulty Gd-IgA1 and leaves your normal, infection-fighting antibodies (IgA, IgG, IgE, IgM) alone.
Biohaven calls this type of medicine a 'TRAP degrader', short for Targeted Removal of Aberrant Protein, and it's part of a broader Biohaven technology called the MoDE platform (Molecular Degraders of Extracellular Proteins). If it reaches approval, BHV-1400 would be the first drug of its kind for IgA nephropathy. Whether it ends up being safer or more effective than the current treatments will depend on the large pivotal trial planned for 2026.
▸What are the side effects of BHV-1400?
Because BHV-1400 is still in early clinical trials, the full list of possible side effects hasn't been worked out yet, identifying side effects is one of the main purposes of a Phase 1 study. Biohaven reported at the J.P. Morgan Healthcare Conference in January 2026 that there had been no drug-related side effects in the first IgA nephropathy patients[5]. In its May 27, 2026 update, Biohaven said most side effects in patients had been mild and went away on their own, with no serious or severe side effects, no one stopping the drug and no notable rise in liver tests[1]. More complete safety information will come from the larger pivotal trial starting in 2026.
▸How is BHV-1400 taken?
Given as an injection under the skin (the same way insulin is given). In the Phase 1 healthy-volunteer study, Biohaven has reported 2 single-dose levels. The lowest dose tested, 125 mg, dropped the faulty Gd-IgA1 antibody by a median of 60% within 4 hours and by more than 70% at its lowest point, reached by 8 hours, and kept it down for days[2]. A higher 500 mg dose dropped it by up to 81% and kept it low for weeks from a single injection[6].
The final dose, how often it will be given, and whether patients will be able to give themselves the injection at home are still being decided based on the Phase 1 data, the Phase 3 protocol uses a 500 mg dose by autoinjector[3].
▸Is BHV-1400 FDA approved?
BHV-1400 is currently in phase 1 clinical trials for IgA Nephropathy. It has not yet received FDA approval.
▸How does BHV-1400 compare to Fabhalta for IgA nephropathy?
BHV-1400 and Fabhalta (iptacopan) target IgA nephropathy through completely different mechanisms. Fabhalta is an oral complement Factor B inhibitor that is FDA-approved (August 2024) and works downstream by blocking the alternative complement pathway, which reduces inflammation triggered by IgA immune complexes that have already deposited in the kidney. BHV-1400 is an investigational, upstream-acting bifunctional 'TRAP degrader' designed to selectively bind and clear galactose-deficient IgA1 (Gd-IgA1), the abnormal antibody that initiates IgAN, before it can form pathogenic complexes. Fabhalta is available now and supported by Phase 3 data; BHV-1400 is in a Phase 1 trial in IgA nephropathy patients (NCT07054684), its Phase 3 trial (NCT07642050) is registered but not yet recruiting, and it is not available outside a trial. They are not directly comparable on efficacy because no head-to-head data exist.
▸What are the eligibility requirements for the BHV-1400 trial?
The BHV-1400 IgAN study (ClinicalTrials.gov NCT07054684) is a Phase 1 first-in-patient trial enrolling adults with biopsy-confirmed primary IgA nephropathy. Specific entry criteria, including proteinuria range, eGFR thresholds, background therapy requirements, and washout from prior IgAN-targeted therapies, are listed on the ClinicalTrials.gov record and may be updated as the trial progresses. Patients interested in participating should review the current criteria on ClinicalTrials.gov and discuss eligibility with their nephrologist and a participating study site. Geographic and site-level constraints may further limit who can enroll.
▸Why would a patient consider a Phase 1 trial when approved IgA nephropathy treatments exist?
Most patients with IgA nephropathy should first work through the FDA-approved options with their nephrologist: Tarpeyo (targeted-release budesonide), Filspari (sparsentan), Fabhalta (iptacopan), Vanrafia (atrasentan), Voyxact (sibeprenlimab), and Trutakna (atacicept). A Phase 1 trial like the BHV-1400 study may be worth discussing with a specialist when (1) a patient has continued disease activity despite optimized standard-of-care, (2) they are intolerant of approved therapies, (3) they want to access an upstream-acting, mechanistically distinct approach not yet otherwise available, or (4) they place high personal value on contributing to research. Phase 1 trials carry meaningful uncertainty about both safety and efficacy and should not replace approved therapy unless a clinician concludes it is appropriate.
▸What is the difference between a TRAP degrader and a complement inhibitor?
A TRAP degrader (Biohaven's term for Targeted Removal of Aberrant Proteins) is a bifunctional molecule with two ends: one end binds a disease-driving extracellular protein (in BHV-1400's case, galactose-deficient IgA1, or Gd-IgA1) and the other end engages a clearance receptor that routes the bound protein to the liver for natural breakdown. The result is removal of the disease-causing protein from circulation while sparing closely related normal proteins. A complement inhibitor like Fabhalta (iptacopan) does not remove Gd-IgA1; instead it blocks an enzyme (Factor B) in the alternative complement pathway, dampening the downstream inflammatory cascade triggered after Gd-IgA1 immune complexes deposit in the kidney. The two strategies are complementary in concept, one tries to eliminate the trigger, the other tries to suppress the response, but the selective-removal approach is still investigational, while complement inhibition and several other suppression strategies are already FDA-approved in IgAN.
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 (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 (PR Newswire) · 2025-01-13. Biohaven Highlights Portfolio Progress, Innovation, and Anticipated Milestones at the 43rd Annual J.P. Morgan Healthcare Conference. https://www.prnewswire.com/news-releases/biohaven-highlights-portfolio-progress-innovation-and-anticipated-milestones-at-the-43rd-annual-jp-morgan-healthcare-conference-reports-positive-degrader-data-with-rapid-deep-and-selective-lowering-of-galactose-deficient-ig-302349336.html
- ClinicalTrials.gov · 2026-10-01. A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy. https://clinicaltrials.gov/study/NCT07642050
- Biohaven (Investor Relations) · 2026-08-10. Biohaven Reports Second Quarter 2026 Financial Results and Recent Business Developments. https://ir.biohaven.com/news-releases/news-release-details/biohaven-reports-recent-business-developments-and-second-quarter
- Biohaven (Investor Relations) · January 12, 2026. 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
- Biohaven (Investor Relations) · May 28, 2025. Biohaven Highlights Innovation and Advancement Across MoDE and TRAP Degrader Platform at R&D Day. https://ir.biohaven.com/news-releases/news-release-details/biohaven-highlights-innovation-and-advancement-across-mode-and
- U.S. National Library of Medicine, ClinicalTrials.gov. Study of BHV-1400 in IgA Nephropathy. https://clinicaltrials.gov/study/NCT07054684
- Biohaven Clinical Trials. IgA Nephropathy Study. https://www.biohavenclinicaltrials.com/clinical-studies/igan/
- Biohaven (Investor Relations), SEC filings · March 3, 2025. Biohaven Annual Report on Form 10-K for the fiscal year ended December 31, 2024. https://ir.biohaven.com/financial-filings/sec-filings
- Kidney Disease: Improving Global Outcomes (KDIGO) · September 2025. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). https://kdigo.org/guidelines/iga-nephropathy/
- University of Leicester. Jonathan Barratt, Mayer Professor of Renal Medicine. https://le.ac.uk/people/jonathan-barratt
- UConn Today · February 2026. UConn Participating in Novel Clinical Trial for Curbing the Most Common Type of Kidney Inflammation. https://today.uconn.edu/2026/02/uconn-participating-in-novel-clinical-trial-for-curbing-the-most-common-type-of-kidney-inflammation/
- HCPLive. IgA Nephropathy in 2025: Year in Review. https://www.hcplive.com/view/iga-nephropathy-2025-year-review
- U.S. Food and Drug Administration. TARPEYO (budesonide) delayed-release capsules, Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215935s003lbl.pdf
- U.S. Food and Drug Administration. FILSPARI (sparsentan) tablets, Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216403s003lbl.pdf
- U.S. Food and Drug Administration. FABHALTA (iptacopan) capsules, Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218276s002lbl.pdf
- U.S. Food and Drug Administration. VANRAFIA (atrasentan) tablets, Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219208s000lbl.pdf
- U.S. Food and Drug Administration. VOYXACT (sibeprenlimab-szsi) injection, Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761434s000lbl.pdf
- Novartis · August 7, 2024. Novartis receives FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN). https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-fabhalta-iptacopan-first-and-only-complement-inhibitor-reduction-proteinuria-primary-iga-nephropathy-igan
- Novartis · April 3, 2025. Novartis receives FDA accelerated approval for Vanrafia (atrasentan), the first and only selective endothelin receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN). https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan
- Otsuka Pharmaceutical · November 25, 2025. Otsuka receives FDA accelerated approval for Voyxact (sibeprenlimab-szsi) for reduction of proteinuria in primary IgA nephropathy. https://www.otsuka-us.com/news/otsuka-receives-fda-accelerated-approval-voyxactr-sibeprenlimab-szsi-reduction-proteinuria