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Systemic AL amyloidosis — Treatment Landscape & Competitive Intelligence

Systemic AL amyloidosis (disease) competitive landscape: 8 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

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

Marketed treatment landscape

Approved drugs treating Systemic AL amyloidosis, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Darzalex daratumumab Johnson & Johnson Monoclonal antibody CD38 2015-01-01
Velcade bortezomib Shilpa Proteasome inhibitor 26S proteasome chymotrypsin-like activity 2003-01-01
Cytoxan (Lyophilized) cyclophosphamide Baxter Alkylating agent Tumor cell DNA 1959-01-01
Decadron dexamethasone Generic (originally Merck) Corticosteroid [EPC] Annexin A1, Interleukin-4, Androgen receptor 1958-10-30
Wydase HYALURONIDASE Baxter Endoglycosidase hyaluronic acid 1950-01-01
Velcade Velcade University of Arkansas 26S proteasome non-ATPase regulatory subunit 1, PH and SEC7 domain-containing protein 1, Cathepsin G
Cyclophosphamid Cyclophosphamid Zhejiang University Cytochrome P450 3A4
Darzalex Darzalex Shanghai Henlius Biotech Lymphocyte differentiation antigen CD38

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

  1. Baxter · 3 drugs in Systemic AL amyloidosis
  2. Generic (originally Merck) · 1 drug in Systemic AL amyloidosis
  3. Johnson & Johnson · 1 drug in Systemic AL amyloidosis
  4. Shanghai Henlius Biotech · 1 drug in Systemic AL amyloidosis
  5. Shilpa · 1 drug in Systemic AL amyloidosis
  6. University of Arkansas · 1 drug in Systemic AL amyloidosis
  7. Zhejiang University · 1 drug in Systemic AL amyloidosis

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Every new regulatory action, PDUFA date, or trial completion in Systemic AL amyloidosis:

Cite this brief

Drug Landscape (2026). Systemic AL amyloidosis — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/systemic-al-amyloidosis. Accessed 2026-06-10.

Related

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