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EFLORNITHINE HYDROCHLORIDE
EFLORNITHINE HYDROCHLORIDE is a drug. It is currently FDA-approved (first approved 1990).
At a glance
| Generic name | EFLORNITHINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1990 |
Approved indications
Common side effects
- Hearing loss
- Otitis media
- Pyrexia
- Pneumonia
- Diarrhea
- Increased ALT
- Increased AST
- Decreased neutrophils
- Decreased hemoglobin
- Cough
- Sinusitis
- Upper respiratory tract infection
Serious adverse events
- Skin infection
- Serious adverse reactions (overall)
Key clinical trials
- Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors (PHASE1, PHASE2)
- Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas (PHASE1, PHASE2)
- Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO) (PHASE1, PHASE2)
- DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma (PHASE2)
- Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas (PHASE1, PHASE2)
- An Intermediate Expanded Use Trial of DFMO
- Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PHASE2)
- Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EFLORNITHINE HYDROCHLORIDE CI brief — competitive landscape report
- EFLORNITHINE HYDROCHLORIDE updates RSS · CI watch RSS
Frequently asked questions about EFLORNITHINE HYDROCHLORIDE
What is EFLORNITHINE HYDROCHLORIDE?
EFLORNITHINE HYDROCHLORIDE is a Small molecule drug.
When was EFLORNITHINE HYDROCHLORIDE approved?
EFLORNITHINE HYDROCHLORIDE was first approved on 1990.
What development phase is EFLORNITHINE HYDROCHLORIDE in?
EFLORNITHINE HYDROCHLORIDE is FDA-approved (marketed).
What are the side effects of EFLORNITHINE HYDROCHLORIDE?
Common side effects of EFLORNITHINE HYDROCHLORIDE include Hearing loss, Otitis media, Pyrexia, Pneumonia, Diarrhea, Increased ALT. Serious adverse events: Skin infection, Serious adverse reactions (overall).