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Blood & Immune

Warm Autoimmune Hemolytic Anemia Clinical Trials

Also called wAIHA, warm AIHA, warm antibody autoimmune hemolytic anemia, warm antibody hemolytic anemia

Red blood cells normally live about 120 days. In warm autoimmune hemolytic anemia, antibodies coat them at body temperature, which is where the word warm comes from, and immune cells, mainly in the spleen, remove them early.

FDA-approved medicines

1

Imaavy

Active trials

11

7 recruiting now

Next FDA decision

None set

FDA calendar

Medicines are those whose current FDA label names Warm Autoimmune Hemolytic Anemia, checked October 21, 2026. Corticosteroids and immune globulins count once each. Download the data

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About Warm Autoimmune Hemolytic Anemia

Red blood cells normally live about 120 days. In warm autoimmune hemolytic anemia, antibodies coat them at body temperature, which is where the word warm comes from, and immune cells, mainly in the spleen, remove them early. When the bone marrow cannot keep up, anemia follows, and the broken-down cells can turn the skin and eyes yellow and the urine dark.

Doctors confirm it with blood tests:

  • low hemoglobin and a high reticulocyte count, the young red cells the marrow releases to keep up
  • signs of red cell destruction: high LDH and bilirubin, and low haptoglobin
  • a positive direct antiglobulin test, also called a Coombs test, which finds antibodies on the red cells
  • a search for any condition causing it, such as lupus or a lymphoma, which the 2020 international consensus recommends for everyone

The main treatments, according to that consensus, NORD and the FDA:

  • corticosteroids such as prednisone, the first treatment
  • rituximab, which the consensus says should be considered early in severe cases or when steroids do not work quickly
  • Imaavy (nipocalimab), an IV infusion every 4 weeks, FDA-approved on August 24, 2026 for people 12 and older who take or have taken steroids; in its trial, 24% on the approved dose reached and held a hemoglobin of at least 10 g/dL, a rise of at least 2 g/dL, compared with 8% on placebo
  • other immunosuppressants such as mycophenolate, azathioprine or cyclophosphamide, removal of the spleen, and transfusions when anemia is severe

wAIHA is also linked to a higher risk of blood clots, especially in the weeks after diagnosis.

Common Symptoms of Warm Autoimmune Hemolytic Anemia

Recognizing the signs of Warm Autoimmune Hemolytic Anemia 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.

  • Tiredness and weakness
  • Pale skin
  • Shortness of breath, dizziness or a pounding heartbeat
  • Yellowing of the skin and the whites of the eyes (jaundice)
  • Dark, tea-colored urine
  • An enlarged spleen, which can feel like fullness in the belly

Who Warm Autoimmune Hemolytic Anemia Affects

wAIHA can start at any age, including childhood, but new cases peak between ages 50 and 70, with a median age at onset of 52 (NORD). It may be slightly more common in women.

In most people no cause is found, which doctors call primary wAIHA. In others, called secondary wAIHA, another condition triggers it, such as lupus, a lymphoma, an infection, a medicine or pregnancy, and treating that cause can change the plan.

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Find trials I might fit Answer a few questions and see which open Warm Autoimmune Hemolytic Anemia trials fit your age, location and treatment history.

FDA-Approved Treatments for Warm Autoimmune Hemolytic Anemia

There is currently 1 FDA-approved medication for Warm Autoimmune Hemolytic Anemia. These therapies represent the current standard of care and may be used alongside or compared against investigational treatments in active clinical trials.

nipocalimab
Johnson & Johnson (Janssen)
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

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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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Diagnosis and Testing

wAIHA is an autoimmune disease, not an inherited one. It is diagnosed with blood tests, including a direct antiglobulin (Coombs) test, and a search for any condition causing it, such as lupus or a lymphoma. There is no gene test for it.

Trusted Warm Autoimmune Hemolytic Anemia Resources

Reputable organizations and medical references for learning more about Warm Autoimmune Hemolytic Anemia, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Warm Autoimmune Hemolytic Anemia

Use this Warm Autoimmune Hemolytic Anemia clinical trial finder to see the 7 studies recruiting patients and 4 opening soon in the United States and worldwide, with eligibility criteria in plain English. Of these, 10 test a treatment and 1 is an observational study or registry; each card says which. These studies play a critical role in advancing care for blood & immune 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.

New to trials? What Placebos and Randomization Actually Mean for You (In Plain English) · 4 min readWorried about cost? The Hidden Costs of Joining a Clinical Trial (And How to Get Help Paying for Them) · 4 min read
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.

11 active trials worldwide
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RECRUITINGTreatment trialPhase 1/2Recently updatedNCT07549698

Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease

Intervention: CTX112

Sponsor: CRISPR Therapeutics AG

This is a single-arm, open-label, multicenter, ascending dose Phase 1/2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed/refractory primary Immune Thrombocytopenia (ITP) and relapsed/refractory...

Ages 18 Years+12 locations
Started Jul 2026Updated yesterdayEst. Dec 2033 (~7y 2m)
RECRUITINGTreatment trialPhase 3Recently updatedNCT07086976

A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia

Intervention: rilzabrutinib, placebo

Sponsor: Sanofi

This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA.

Ages 18 Years+105 locations
Started Aug 2025Updated yesterdayEst. May 2028 (~1y 7m)
RECRUITINGTreatment trialPhase 1Recently updatedNCT07083960

OM336 in Autoimmune Cytopenias

Intervention: OM336

Sponsor: Lakefront Biotherapeutics West LLC

An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.

Ages 18 Years to 75 Years7 locations
Started Aug 2025Updated 1 month agoEst. Dec 2026 (~2 months)
NOT YET RECRUITINGTreatment trialPhase 1/2Recently updatedNCT07738822

A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA

Intervention: Velinotamig specified dose on specified days.

Sponsor: Cullinan Therapeutics Inc.

A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) to evaluate safety and tolerability.

Ages 18 Years to 80 Years1 location
Expected to start Dec 2026Updated 2 months agoEst. Jan 2029 (~2y 3m)
RECRUITINGTreatment trialPhase 1Updated a few months agoNCT06534021

IASO-782 in Autoimmune Hematological Diseases

Intervention: IASO-782 injection, placebo

Sponsor: Shanghai IASO Biotechnology Co., Ltd

This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).

Ages 18 Years to 65 Years2 locations
Started Aug 2024Updated 4 months agoEst. Oct 2027 (~11 months)
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Find Warm Autoimmune Hemolytic Anemia trials near you, ranked by distance →
Active trial locations28 cities in the US
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Trial Pipeline

Jan 2021 to Oct 2031
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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
Always talk to your doctor before considering a clinical trial.

Patient Communities

Connect with other Warm Autoimmune Hemolytic Anemia 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 Warm Autoimmune Hemolytic Anemia treatments, clinical trial participation, and day-to-day disease management.

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Related Conditions

Conditions that share genes, symptoms or treatments with Warm Autoimmune Hemolytic Anemia, followed by others in the blood & immune category. Patients with Warm Autoimmune Hemolytic Anemia may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Warm Autoimmune Hemolytic Anemia News and Guides

Trial Friend articles about Warm Autoimmune Hemolytic Anemia, newest first

Companies Developing Warm Autoimmune Hemolytic Anemia Treatments

3 pharmaceutical companies have Warm Autoimmune Hemolytic Anemia in their rare disease portfolio

Frequently Asked Questions About Warm Autoimmune Hemolytic Anemia