ORPHA:90033
Autoimmune hemolytic anemia, warm type
Also known as: Warm AIHA · wAHA · wAIHA
Publications
1,116
86.7th percentile
Trials
25
Interventional, condition-specific
Researchers
989
Distinct authors in sample
Gene link
—
Readiness
3/6
Stages with a signal
Clinical definition (Orphanet)
Warm autoimmune hemolytic anemia is the most common form of autoimmune hemolytic anemia defined by the presence of warm autoantibodies against red blood cells (autoantibodies that are active at temperatures between 37-40°C).
How rare: 1-9 / 100 000 — about one to nine people per hundred thousand.
Cross-references
Joined from Mondo / Orphanet. MeSH labels may enter searches; UMLS / OMIM / NCIT are stored for reference.
- MONDO:0019532
- UMLS:C0272118
- NCIT:C162611
Additional Mondo synonyms (2)
Warm Autoimmune Hemolytic Anemia · warm AIHA
Research stages
Trial readiness signals
Where this condition sits on an open-data research pipeline — not how close a treatment is, and not medical advice. Empty stages often mean “not in these databases under this Mondo ID,” not “impossible.”
3/6 stages with a signal
An interventional trial matched this condition name on ClinicalTrials.gov — see trials below.
- Gene identifiedNot found
No GenCC disease–gene assertion in this build
- LiteraturePresent
1,116 matched papers (874 in last 10 years) Source
- Phenotype characterisedPresent
27 HPO annotations (e.g. Fatigue; Splenomegaly; Reticulocytosis) Source
- Animal modelNot found
No Alliance genotype “model of” associations via Monarch for these Mondo IDs
- Orphan designationNot found
No FDA or EMA orphan-drug designation matched this disease via UMLS or preferred name Source
- Interventional trialPresent
25 matched on ClinicalTrials.gov (7 recruiting in sample)
Biology
Genes and phenotypes
Gene–disease validity from GenCC, plus phenotypes and animal models joined from Monarch Initiative via Mondo ID — not a clinical diagnosis aid.
Do we know what causes it?
Not yet — the cause hasn't been pinned down in GenCC.
No strong gene–disease assertion joined for this Orphanet entity.
Phenotypes (Monarch / HPO)
27
Associated phenotypes · MONDO:0019532
- Fatigue
- Splenomegaly
- Reticulocytosis
- Palpitations
- Hemoglobinuria
Showing 5 of 27 — open Monarch for the full list.
Animal models (Monarch / Alliance)
None returned for this Mondo ID. Empty here is not proof that no model organism work exists under another name or gene.
Monarch fetch 2026-07-27
Therapies
Designations, candidates, and chemicals
FDA OOPD and EMA orphan designations, Open Targets clinical candidates, and CTD chemical associations via MyDisease.info. These never change the interventional-trial headline.
Orphan designation (FDA · EMA)
No designation matched this disease via UMLS or preferred name on the FDA OOPD mirror or EMA orphan register. Absence here is not proof that none exists under another wording.
Open Targets candidates
No drugs or clinical candidates returned for this Mondo ID on Open Targets.
CTD chemicals (MyDisease.info)
No CTD chemical associations returned for this Mondo ID.
Literature
Is anyone studying this?
1,116
1,116 papers have been published on this condition. That is a real research literature — still far smaller than common diseases (breast cancer: over 700,000 papers). Median papers in the last 10 years for a rare disease in this dataset (publications denominator n=3967) is 59.
1,116 papers since the earliest indexed year in this search — median last-10-year count for a rare disease in this dataset is 59 (publications denominator n=3967).
874 in the last 10 years · medium confidence · 86.7th percentile (publications denominator)
Phrase hits: 1,116 · MeSH hits: 0
Who's working on it?
989
Distinct author names in 200 sampled papers — named people below.
Who's working on it?
People publishing on this condition (sampled Europe PMC records). Affiliation is the most recent found in that sample.
- 01Fattizzo B16 papers · 2026
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Ematologia, Milan, Italy.
Papers in Europe PMC - 02Barcellini W15 papers · 2026
Department of Hematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Papers in Europe PMC - 03Murakhovskaya I9 papers · 2026
Department of Hematology and Oncology, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.
Papers in Europe PMC - 04Branch DR5 papers · 2024
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
Papers in Europe PMC - 05
- 06Yang C5 papers · 2026
Department of Transfusion, Zhongshan Hospital, Fudan University, Shanghai, China.
Papers in Europe PMC - 07Chen M4 papers · 2026
Department of Hematology, Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, Beijing, China.
Papers in Europe PMC - 08Crivera C4 papers · 2025
Janssen Global Services, LLC, Horsham, PA, United States
Papers in Europe PMC - 09Michel M4 papers · 2024
Department of Internal Medicine, National Referral Center for Adult Immune Cytopenias Henri Mondor University Hospital, Service de Medecine Interne, CHU Hopital Henri-Mondor, Assistance Publique Hôpitaux de Paris, Université Paris-Est Créteil, 51 Av du Mal de Lattre de Tassigny, 94010 Creteil Cedex, France. Electronic address: marc.michel2@aphp.fr.
Papers in Europe PMC - 10Mitrović M4 papers · 2023
Clinic of Hematology, University Clinical Center of Serbia, Belgrade, Serbia.
Papers in Europe PMC
Clinical research
Is a treatment being tested?
25
interventional trials for this specific condition
25 interventional trials matched this specific condition name; 7 currently recruiting in our sample. 47 trials are registered for autoimmune hemolytic anemia, the broader category — shown separately because they may or may not enrol this specific subtype.
Data as of 9 September 2026
25 interventional trials — more than 77.2% of diseases in the trials denominator have none at all (5501 of 7126; this disease is at the 95.5th percentile).
medium confidence · 95.5th percentile (trials denominator)
Recruiting interventional trials
From the matched ClinicalTrials.gov set
25 interventional trials matched after quoted-phrase search and title/condition post-filter.
- NCT07083960·RECRUITING·OM336 in Autoimmune Cytopenias
Uncertain·Conditions: AIHA - Warm Autoimmune Hemolytic Anemia · AIHA - Cold Autoimmune Hemolytic Anemia · ITP - Immune Thrombocytopenia·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT07039422·RECRUITING·Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
Confirmed·Conditions: Primary Immune Thrombocytopenia · Warm Autoimmune Hemolytic Anemia·Matched via name phraseBoth providers judged relevant.
- NCT05925023·RECRUITING·Sirolimus in the Treatment of Refractory/Relapsed wAIHA
Confirmed·Conditions: Warm Autoimmune Hemolytic Anemia·Matched via name phraseBoth providers judged relevant.
- NCT07530380·RECRUITING·UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
Confirmed·Conditions: AIHA - Warm Autoimmune Hemolytic Anemia · UCART·Matched via name phraseBoth providers judged relevant.
- NCT07086976·RECRUITING·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
Confirmed·Conditions: Autoimmune Haemolytic Anaemia·Matched via name phraseBoth providers judged relevant.
- NCT07549698·RECRUITING·Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Confirmed·Conditions: Warm Autoimmune Hemolytic Anemia (WAIHA) · ITP - Immune Thrombocytopenia · Warm Autoimmune Hemolytic Anemia · Immune Thrombocytopenic Purpura·Matched via name phraseBoth providers judged relevant.
- NCT06847607·NOT YET RECRUITING·A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)
Uncertain·Conditions: AIHA - Warm Autoimmune Hemolytic Anemia · AIHA - Cold Autoimmune Hemolytic Anemia·Matched via name phraseAt least one provider returned uncertain or parent-category.
Broader category: autoimmune hemolytic anemia
47
Interventional trials for the parent category, exclusive of NCT IDs already counted above. Eligibility for this subtype is not guaranteed.
Worth raising with a clinician. How we count trials.
Recruiting under the broader category
- NCT07091370·NOT YET RECRUITING·Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy
Likely noise·Conditions: AIHA - Cold Autoimmune Hemolytic Anemia·Matched via name phraseBoth providers judged irrelevant.
- NCT07441525·RECRUITING·UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
Parent·Conditions: Autoimmune Hemolytic Anemia · Primary Immune Thrombocytopenic Purpura · Evans Syndrome·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07603557·NOT YET RECRUITING·Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
Parent·Conditions: Chronic Immune Thrombocytopenia · Autoimmune Hemolytic Anemia·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07629596·RECRUITING·Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)
Uncertain·Conditions: Systemic Lupus Erythematosus · Autoimmune Hemolytic Anemia (AIHA)·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT05089227·RECRUITING·Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
Uncertain·Conditions: Prolonged Anticoagulation · Venous Thromboembolic Disease · Autoimmune Hemolytic Anemia·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT04138927·ENROLLING BY INVITATION·A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Confirmed·Conditions: Warm Antibody Autoimmune Hemolytic Anemia·Matched via name phraseBoth providers judged relevant.
- NCT07175493·RECRUITING·A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
Parent·Conditions: Autoimmune Cytopenia · Immune Thrombocytopenia (ITP) · Autoimmune Hemolytic Anemia · Evans Syndrome·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07190261·NOT YET RECRUITING·A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
Uncertain·Conditions: Autoimmune Hemolytic Anemia·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT06888960·RECRUITING·Safety Study of CC312 in Autoimmune Disease Patients
Parent·Conditions: Systemic Lupus Erythematosus (SLE) · Idiopathic Inflammatory Myopathy (IIM) · Systemic Sclerosis (SSc) · Rheumatoid Arthritis (RA)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07518277·NOT YET RECRUITING·A Multicenter, Prospective, Randomized Controlled Study Comparing Glucocorticoid Combined With Sirolimus With Monotherapy of Glucocorticoid in the Treatment of Newly Diagnosed Mild Autoimmune Hemolytic Anemia
Uncertain·Conditions: Autoimmune Hemolytic Anemia (AIHA)·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT07361094·RECRUITING·Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases
Uncertain·Conditions: Relapsed/Refractory Systemic Lupus Erythematosus · Relapsed/Refractory Systemic Sclerosis · Relapsed/Refractory Idiopathic Inflammatory Myopathies · Relapsed/Refractory sjögren's Syndrome·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT07574073·NOT YET RECRUITING·CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia
Uncertain·Conditions: Anti-CD20 Monoclonal Antibody · BTK Inhibitors · Immune Thrombocytopenia (ITP) · Autoimmune Hemolytic Anemia (AIHA)·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT06978738·NOT YET RECRUITING·UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
Parent·Conditions: Systemic Lupus Erythematosus · Autoimmune Hemolytic Anemia · Myasthenia Gravis · Systemic Sclerosis·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07585071·NOT YET RECRUITING·IASO206 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
Uncertain·Conditions: Autoimmune Hemolytic Anemia · Relapsed/Refractory·Matched via name phraseAt least one provider returned uncertain or parent-category.
- NCT07689604·NOT YET RECRUITING·META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
Uncertain·Conditions: Autoimmune Hemolytic Anemia (AIHA)·Matched via name phraseAt least one provider returned uncertain or parent-category.
Observational and natural-history studies
1 observational study matches this condition. These do not test a treatment and are not counted in the interventional-trial headline, but they are genuine research: natural-history work often defines the endpoints needed for a future rare-disease trial, and families may be able to enroll.
Recruiting or not-yet-recruiting
- NCT07019038·RECRUITING·National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
Parent·Conditions: AIHA - Warm Autoimmune Hemolytic Anemia · AIHA - Cold Autoimmune Hemolytic Anemia · Autoimmune Hemolytic Anemia Mixed Type·Matched via name phraseBoth providers judged relevant only to a broader parent category.
Other registries (secondary)
Broader net from EU CTIS, ISRCTN, and ICTRP when available — deduped against ClinicalTrials.gov IDs already counted above. Dual-model LLM relevance gates what we keep. These rows are not added to the interventional headline.
raw 15 · after dedupe 15 · already on CT.gov 0 · kept 7 · parent 1 · uncertain 5 · dropped 2 · fetched 2026-07-27
Source notes: ictrp: Error: ICTRP public search unavailable (WHO portal is SPA-only; SOAP needs partnership). Tried: https://apps.who.int/tri
- isrctn·ISRCTN13110963·No longer recruiting·A phase 3 study of obexelimab in patients with warm autoimmune hemolytic anemia
Confirmed — Both providers judged relevant.
- isrctn·ISRCTN14903256·No longer recruiting·Study of the efficacy and safety of parsaclisib in participants with primary warm autoimmune hemolytic anemia
Confirmed — Both providers judged relevant.
- ctis·2024-517972-39-00·Authorised, ongoing·A phase 3, multicenter, randomized, double-blind, placebo- controlled, parallel-group study with an open-label period and long-term extension to assess the efficacy and safety of rilzabrutinib in participants with warm autoimmune hemolytic anemia (wAIHA)
Confirmed — Both providers judged relevant.
- ctis·2024-510635-21-00·Authorised, recruiting·A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)
Confirmed — Both providers judged relevant.
- ctis·2023-509441-13-00·Expired·A multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia (LUMINA 2)
Confirmed — Both providers judged relevant.
- ctis·2023-505321-14-00·Expired·Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension
Confirmed — Both providers judged relevant.
- ctis·2022-501005-12-00·Cancelled·A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, WITH A SAFETY AND DOSE CONFIRMATION RUN-IN PERIOD, TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA (SAPHIARE)
Confirmed — Both providers judged relevant.
Broader / parent-category hits (1)
- ctis·2025-521286-27-00·Authorised, ongoing·INCA000585-201 - A PHASE 2A, OPEN-LABEL, MULTI-CENTER STUDY OF TAFASITAMAB IN ADULT PARTICIPANTS WITH AUTOIMMUNE BLOOD CELL DISORDERS
Parent category — Both providers judged relevant only to a broader parent category.
Uncertain / not reviewed (5)
- ctis·2025-523845-90-00·Authorised, recruiting·Safety and Preliminary Efficacy of CTX112 in Adult Participants with Relapsed/Refractory Hematologic Autoimmune Disease
Uncertain — At least one provider returned uncertain or parent-category.
- ctis·2024-518231-11-00·Cancelled·Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have
Previously Benefited from Ianalumab (VAY RE-HIT)
Uncertain — At least one provider returned uncertain or parent-category.
- ctis·2023-509793-38-00·Authorised, ongoing·Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like monoclonal B-cell lymphocytosis. CLL2323
Uncertain — At least one provider returned uncertain or parent-category.
- ctis·2024-513191-17-00·Authorised, ongoing·API-AHAI - Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
Uncertain — At least one provider returned uncertain or parent-category.
- ctis·2023-507067-19-00·Cancelled·Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4)
Uncertain — At least one provider returned uncertain or parent-category.
Where to find support
Condition-specific patient organisations, when Orphanet lists them, are on the disease’s Orphanet page. We also link umbrella groups that support undiagnosed and ultra-rare families.
Orphanet entry for Autoimmune hemolytic anemia, warm type — check Associations / patient organisations on that page.
India — NPRD
Last verified 2026-07-26This ORPHAcode is not on our curated NPRD list (direct or Mondo-parent match). That does not decide clinical eligibility; families in India should ask a notified Centre of Excellence about current coverage.
Hand-curated for this project. ORPHAcode mappings are best-effort and may be incomplete or imprecise for umbrella categories. Parent (Mondo) matches mean the policy lists a broader category — confirm eligibility with a Centre of Excellence. Financial entitlements summarised from public policy statements and may change. This is not official government guidance.
How we counted this
Europe PMC query (preferred label + any corrected label + Orphanet and Mondo exact synonyms, stoplisted; unioned with resolved MeSH labels when available). UMLS / OMIM / NCIT cross-references are stored on the overview but are not added to the query string.
"Autoimmune hemolytic anemia, warm type" OR "Warm AIHA" OR "wAIHA" OR "Warm Autoimmune Hemolytic Anemia"
ClinicalTrials.gov query (quoted phrases + MeSH via query.cond, plus recall-expansion terms when used):
"Autoimmune hemolytic anemia, warm type" OR "Warm AIHA" OR "wAIHA" OR "Warm Autoimmune Hemolytic Anemia"
Interventional trials matched via: phrase (mesh = registered under a MeSH descriptor no name phrase would catch; recall-expansion = gene / selected parent terms used only for trials).
Study-type breakdown: 25 interventional · 1 observational · 1 expanded access. Only interventional studies enter the trial headline.
Parent-category trials query:
"autoimmune hemolytic anemia"
Query health: ok — strategies attempted: phrase; with hits: phrase
Run this search on ClinicalTrials.gov
Synonyms dropped by stoplist: wAHA
Confidence reasoning
- Preferred label is multi-word and distinctive
- 1 synonym(s) dropped by stoplist (may under-count)
- No label/synonym collisions with other diseases in this corpus
Ingested 2026-07-26T01:52:17.377Z
