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Last reviewed 2026-06-10 · How we verify

Cold autoimmune hemolytic anemia — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cold autoimmune hemolytic anemia (disease) competitive landscape: 2 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

2 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Cold autoimmune hemolytic anemia, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	Line of therapy	First approval
Enjaymo	SUTIMLIMAB	Bioverativ Therapeutics Inc	Classical Complement Pathway Inhibitor [EPC]	Complement C1s subcomponent		2022-01-01
ENJAYMO	SUTIMLIMAB-JOME	RECORDATI RARE DISEASES, INC.	Classical Complement Pathway Inhibitor [EPC]	Complement C1s subcomponent

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Bioverativ Therapeutics Inc · 1 drug in Cold autoimmune hemolytic anemia
RECORDATI RARE DISEASES, INC. · 1 drug in Cold autoimmune hemolytic anemia

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Cite this brief

Drug Landscape (2026). Cold autoimmune hemolytic anemia — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/cold-autoimmune-hemolytic-anemia. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing