BAY 3401016
An investigational treatment for Alport Syndrome.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify BAY 3401016 wherever you encounter it, plus the key facts at a glance.
- Generic name
- BAY 3401016
- Development codes
- BAY 3401016, BAY3401016
- Drug class
- Monoclonal antibody (anti-Semaphorin 3A)
- Manufacturer
- Bayer (with Evotec)
- How it's taken
- Weekly injections for 24 weeks, in a trial only
An investigational antibody from Bayer, developed with Evotec, that blocks a protein called Semaphorin 3A in the hope of lowering protein in the urine and slowing kidney decline in Alport syndrome [1].
Its Phase 2a ASSESS trial in adults aged 18 to 45 has finished enrolling [4]. It is not FDA approved, and no results have been published.
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How BAY 3401016 works
In Alport syndrome, faulty type IV collagen weakens the filters in the kidney, and the cells that line them, called podocytes, are damaged over time, letting protein leak into the urine. Evotec, Bayer's partner, describes changes in podocytes as a key feature of Alport syndrome [2], and Bayer says Semaphorin 3A is thought to be involved in the progression of kidney damage.
BAY 3401016 is a monoclonal antibody designed to block it [1]. ClinicalTrials.gov describes the hope that it may prevent proteinuria and slow the loss of kidney function, which the ASSESS trial is testing [4]. It does not correct the collagen gene.
Clinical trial results
ASSESS (NCT07211685) is a randomized, double-blind, placebo-controlled Phase 2a trial, meaning neither participants nor doctors know who gets the drug or a dummy injection, with an extension phase, in about 60 adults aged 18 to 45 with rapidly progressing Alport syndrome. It enrolls men with X-linked Alport syndrome and men or women with autosomal recessive Alport syndrome who have an eGFR, a measure of how well the kidneys filter, of at least 45 and a urine albumin to creatinine ratio (UACR) of at least 500mg/g.
Its main measure is UACR, compared with the start, averaged over weeks 16, 20 and 24 of treatment. It began on November 19, 2025, has about 5 US sites among roughly 50 worldwide, and lists primary completion in November 2027 [4]. ClinicalTrials.gov lists it as active and no longer recruiting [4], and the Alport Syndrome Foundation says enrollment was complete as of September 2026 [3].
Main registered trial: NCT07211685 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Side effects and safety
No safety results have been published. Side effects and serious side effects are a secondary measure of the ASSESS trial, tracked until 90 days after treatment ends [4]. No clinical hold has been reported.
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 BAY 3401016
Given once a week for 24 weeks, on top of any background treatment a person already takes [4]. Bayer has not published the route. According to the Alport Syndrome Foundation, the first dose is given as an intravenous infusion plus an injection under the skin, and later doses are injections under the skin, once a week for 6 months [3].
Development history
BAY 3401016 came from a kidney research collaboration that Bayer and Evotec began in 2016, and Evotec can earn milestones and royalties [2]. Bayer said in December 2025 that the FDA had granted it Fast Track and Orphan Drug designations, and called ASSESS its first study in patients [1]. Bayer has not announced filing plans.
Explore Alport Syndrome trials
Other Alport Syndrome treatments
Common questions about BAY 3401016
▸What is BAY 3401016?
An investigational antibody from Bayer, developed with Evotec, that blocks a protein called Semaphorin 3A in the hope of lowering protein in the urine and slowing kidney decline in Alport syndrome [1]. Its Phase 2a ASSESS trial in adults aged 18 to 45 has finished enrolling [4]. It is not FDA approved, and no results have been published.
▸How does BAY 3401016 work?
In Alport syndrome, faulty type IV collagen weakens the filters in the kidney, and the cells that line them, called podocytes, are damaged over time, letting protein leak into the urine. Evotec, Bayer's partner, describes changes in podocytes as a key feature of Alport syndrome [2], and Bayer says Semaphorin 3A is thought to be involved in the progression of kidney damage. BAY 3401016 is a monoclonal antibody designed to block it [1]. ClinicalTrials.gov describes the hope that it may prevent proteinuria and slow the loss of kidney function, which the ASSESS trial is testing [4]. It does not correct the collagen gene.
▸What are the side effects of BAY 3401016?
No safety results have been published. Side effects and serious side effects are a secondary measure of the ASSESS trial, tracked until 90 days after treatment ends [4]. No clinical hold has been reported.
▸How is BAY 3401016 taken?
Given once a week for 24 weeks, on top of any background treatment a person already takes [4]. Bayer has not published the route. According to the Alport Syndrome Foundation, the first dose is given as an intravenous infusion plus an injection under the skin, and later doses are injections under the skin, once a week for 6 months [3].
▸Is BAY 3401016 FDA approved?
BAY 3401016 is currently in phase 2 clinical trials for Alport Syndrome. It has not yet received FDA approval.
▸What is BAY 3401016 and how could it help Alport syndrome?
An investigational Bayer antibody that blocks Semaphorin 3A, a protein linked to damage of the kidney's filtering cells.
Goal: lower protein in the urine and slow loss of kidney function, which the ASSESS trial is testing.
Status: Phase 2a; no results published.
Source: Bayer release, December 4, 2025; ClinicalTrials.gov NCT07211685.
▸Is the Bayer Alport syndrome trial still recruiting?
No. ClinicalTrials.gov lists ASSESS as active and no longer recruiting.
Enrollment: the Alport Syndrome Foundation says it was complete as of September 2026.
Primary completion: estimated for November 2027.
Source: ClinicalTrials.gov NCT07211685, updated October 29, 2026; Alport Syndrome Foundation trials page.
▸How is BAY 3401016 given?
Once a week for 24 weeks in the ASSESS trial.
Route: Bayer has not published it; according to the Alport Syndrome Foundation, the first dose is an infusion plus an injection under the skin, and the rest are injections under the skin.
Source: ClinicalTrials.gov NCT07211685; Alport Syndrome Foundation trials page.
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.
- Bayer (Business Wire) · 2025-12-04. Bayer Starts Phase IIa Study for Treatment of Patients With Alport Syndrome. https://www.businesswire.com/news/home/20251203769695/en
- Evotec · 2025-12-04. Evotec partner Bayer starts Phase 2 study for treatment of patients with Alport syndrome. https://www.evotec.com/news/evotec-partner-bayer-starts-phase-2-study-for-treatment-of-patients-with-alport-syndrome
- Alport Syndrome Foundation. Clinical Trials - Active Trials. https://alportsyndrome.org/current-past-clinical-trials/
- ClinicalTrials.gov. A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome (ASSESS). https://clinicaltrials.gov/study/NCT07211685