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autoimmune hemolytic anemia (AHA) - Clinical Profile, Treatments & Trials | Kisho | Kisho

Treatment

Compiled from FDA-approved drug records, orphan drug designations, and FDA Adverse Event Reporting System (FAERS) safety data. GeneReviews management guidance is included where available.

1 FDA-approved treatment is available for autoimmune hemolytic anemia, including SUTIMLIMAB-JOME (ENJAYMO, approved 2022). An additional 10 compounds hold orphan drug designation.

Approved Therapies

Brand Name	Generic Name	Mechanism	Approved	Market Status
ENJAYMO	SUTIMLIMAB-JOME	—	2022	Available

Orphan Drug Designations

The following drugs have received orphan drug designation from the FDA for autoimmune hemolytic anemia. Orphan designation reflects regulatory interest and does not indicate approval for treatment.

Brand Name	Generic Name	Sponsor	Designated	Exclusivity End	Designation Status
Bispecific humanized IgG4 BCMA-directed CD3 T cell engager antibody	Bispecific humanized IgG4 BCMA-directed CD3 T cell engager antibody	Ouro Medicines, Ltd.	2025	—	Designated
rilzabrutinib	rilzabrutinib	Sanofi US Services Inc.	2025	—	Designated
a humanized IgG4 monoclonal antibody, produced in CHO cells, that binds to and inhibits the activated form of the classical complement pathway (CP) specific serine protease, C1s

Gene therapy approaches for autoimmune hemolytic anemia have been reported in the published literature.

Clinical Trials

57 trials found

Explore Trials

Research Landscape

Sourced from ClinicalTrials.gov and PubMed. Publication types are classified using NLM-curated article metadata; research type breakdowns reflect the nature of published work for this disease.

57 clinical trials registered, 27 recruiting. Interventions under study include drug therapy, biologic therapy, and other interventions. Pipeline includes 5 PHASE3, 12 PHASE2, 20 PHASE1. Research is sponsored by a mix of industry and academic institutions.

NCT ID	Title	Phase	Sponsor	Status
[NCT07083960](https://clinicaltrials.gov/study/NCT07083960)	OM336 in Autoimmune Cytopenias	PHASE1	Lakefront Biotherapeutics West LLC	RECRUITING
[NCT04645199](https://clinicaltrials.gov/study/NCT04645199)	National Longitudinal Cohort of Hematological Diseases	—	Institute of Hematology & Blood Diseases Hospital, China	RECRUITING
[NCT06534021](https://clinicaltrials.gov/study/NCT06534021)	IASO-782 in Autoimmune Hematological Diseases	PHASE1	Shanghai IASO Biotechnology Co., Ltd	RECRUITING
[NCT07453368](https://clinicaltrials.gov/study/NCT07453368)	Orelabrutinib in the Treatment of Relapsed/Refractory AIHA	PHASE2	Peking Union Medical College Hospital	RECRUITING
[NCT07361094](https://clinicaltrials.gov/study/NCT07361094)	Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases	PHASE1	Beijing Boren Hospital	RECRUITING

314 publications have been identified in PubMed for autoimmune hemolytic anemia. Research spans Case Report / Case Series (46%), Review / Meta-Analysis (22%), and Epidemiology / Natural History (10%).

Research Type	Count	% of Total
Patient case studies	145	46%
Research summaries	70	22%
Disease patterns and progression	31	10%
Clinical study results	27	9%
Other research	16	5%
Testing and diagnosis research	11

Recent Publications

Mozhaev MA (2026). [PMID: 42042680](https://pubmed.ncbi.nlm.nih.gov/42042680/). *Pediatr Rep*. [Case Report / Case Series]
Sil S (2026). [PMID: 41077552](https://pubmed.ncbi.nlm.nih.gov/41077552/). *Transfus Med*. [Case Report / Case Series]
Lee A (2026). [PMID: 41359083](https://pubmed.ncbi.nlm.nih.gov/41359083/). *Drugs*. [Review / Meta-Analysis]
Flores-Jiménez JA (2026). [PMID: 41797180](https://pubmed.ncbi.nlm.nih.gov/41797180/). *Hematol Transfus Cell Ther*. [Review / Meta-Analysis]
Ruiz Lopez JN (2026). [PMID: 41846299](https://pubmed.ncbi.nlm.nih.gov/41846299/). *Br J Haematol*. [Basic Science / Preclinical]
F A (2026). [PMID: 41763661](https://pubmed.ncbi.nlm.nih.gov/41763661/). *BMJ Case Rep*. [Case Report / Case Series]
Azinge N (2026). [PMID: 42064491](https://pubmed.ncbi.nlm.nih.gov/42064491/). *Cureus*. [Case Report / Case Series]
Pitaro AT (2026). [PMID: 42255844](https://pubmed.ncbi.nlm.nih.gov/42255844/). *Cureus*. [Case Report / Case Series]
Furqan M (2026). [PMID: 42254262](https://pubmed.ncbi.nlm.nih.gov/42254262/). *Ann Med Surg (Lond)*. [Case Report / Case Series]
Yoshihara K (2026). [PMID: 41713183](https://pubmed.ncbi.nlm.nih.gov/41713183/). *Transfus Apher Sci*. [Case Report / Case Series]

Kisho

autoimmune hemolytic anemia

Overview

Clinical Presentation

Explore clinical features

Diagnosis

Treatment

Approved Therapies

Orphan Drug Designations

Clinical Trials

Prognosis

Research Landscape

Recent Publications

Medical References

External Resources

OMIM

Orphanet

GARD

Questions for Your Care Team

Questions for Your Care Team

Latest News & Developments

Targeting type I interferon in lupus autoimmune haemolytic anaemia: first report with anifrolumab.

J&J looks to widen Imaavy’s use; $300M backs rare disease drug launch

French protocol for the diagnosis and management of autoimmune hemolytic anemia in adults.

Bone Marrow Pathology in Cold Agglutinin-Mediated Autoimmune Hemolytic Anemia: A Study of 56 Cases.

Revolutionary Therapy Cured Three "Incurable" Autoimmune Diseases in a Patient

autoimmune hemolytic anemia

Overview

Clinical Presentation

Explore clinical features

Diagnosis

Treatment

Approved Therapies

Orphan Drug Designations

Clinical Trials

Prognosis

Research Landscape

Recent Publications

Medical References

External Resources

OMIM

Orphanet

GARD

Subtypes

Related Diseases

Questions for Your Care Team

Questions for Your Care Team

Latest News & Developments

Targeting type I interferon in lupus autoimmune haemolytic anaemia: first report with anifrolumab.

J&J looks to widen Imaavy’s use; $300M backs rare disease drug launch

French protocol for the diagnosis and management of autoimmune hemolytic anemia in adults.

Bone Marrow Pathology in Cold Agglutinin-Mediated Autoimmune Hemolytic Anemia: A Study of 56 Cases.

Revolutionary Therapy Cured Three "Incurable" Autoimmune Diseases in a Patient