Last reviewed 2026-05-14 · How we verify

LYMPHIR (DENILEUKIN DIFTITOX-CXDL)

CITIUS PHARMS · FDA-approved approved Quality 34/100

LYMPHIR (generic name: DENILEUKIN DIFTITOX-CXDL) is a CD25-directed Cytotoxin [EPC] drug developed by CITIUS PHARMS. It is currently FDA-approved for Relapsed or Refractory CTCL.

Denileukin Diftitox-CXDL (Lymphir), marketed by Citius Pharms, is positioned as a treatment for relapsed or refractory cutaneous T-cell lymphoma (CTCL). The drug's key strength lies in its unique mechanism of action, which differentiates it in the CTCL market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Generic name	DENILEUKIN DIFTITOX-CXDL
Sponsor	CITIUS PHARMS
Drug class	CD25-directed Cytotoxin [EPC]
Therapeutic area	Other
Phase	FDA-approved

Approved indications

Relapsed or Refractory CTCL

Boxed warnings

WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity [see Dosage and Administration ( 2.1 , 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )

Common side effects

increased transaminases
albumin decreased
nausea
edema
hemoglobin decreased
fatigue
musculoskeletal pain
rash
chills
constipation
pyrexia
capillary leak syndrome

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

LYMPHIR CI brief — competitive landscape report
LYMPHIR updates RSS · CI watch RSS
CITIUS PHARMS portfolio CI

Frequently asked questions about LYMPHIR

What is LYMPHIR?

LYMPHIR (DENILEUKIN DIFTITOX-CXDL) is a CD25-directed Cytotoxin [EPC] drug developed by CITIUS PHARMS, indicated for Relapsed or Refractory CTCL.

What is LYMPHIR used for?

LYMPHIR is indicated for Relapsed or Refractory CTCL.

Who makes LYMPHIR?

LYMPHIR is developed and marketed by CITIUS PHARMS (see full CITIUS PHARMS pipeline at /company/citius-pharms).

What is the generic name of LYMPHIR?

DENILEUKIN DIFTITOX-CXDL is the generic (nonproprietary) name of LYMPHIR.

What drug class is LYMPHIR in?

LYMPHIR belongs to the CD25-directed Cytotoxin [EPC] class. See all CD25-directed Cytotoxin [EPC] drugs at /class/cd25-directed-cytotoxin-epc.

What development phase is LYMPHIR in?

LYMPHIR is FDA-approved (marketed).

What are the side effects of LYMPHIR?

Common side effects of LYMPHIR include increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue.

Drug class: All CD25-directed Cytotoxin [EPC] drugs
Manufacturer: CITIUS PHARMS — full pipeline
Therapeutic area: All drugs in Other
Indication: Drugs for Relapsed or Refractory CTCL

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