Eflornithine 11.5% cream
Requires a prescription from a doctor or prescriber
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Pregnancy
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
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5 branded products available
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Vaniqa 11.5% cream
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View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 13 · Randomised trials: 14 · 1987–2026
Showing the 50 most relevant studies, sorted by most relevant.
Gérardo Priotto, S Kasparian, Wilfried Mutombo, et al.
The Lancet, 2009
- Eflornithine
- Congo
- Fever
Lifeng Yang, Yan Wang, Shasha Hu, et al.
Frontiers in Oncology, 2023
Objectives: To evaluate the efficacy of Difluoromethylornithine (DFMO) chemoprevention in the high-risk population for colorectal cancer (CRC). Methods: Meta-analysis was conducted to assess the caliber of the included literature by searching five databases for randomized controlled trials of DFMO chemoprevention in the high-risk population of CRC, with RevMan 5.4, Stata 15.0 and TSA 0.9.5.10 employed to statistically analyze the extracted data. Grade profiler 3.6 was employed for grading the evidence for the outcome indicators (disease progression and adenoma incidence). Results: Six trials were finally included in this research, with the collective data indicating that the DFMO combination therapy was efficacious in lowering the incidence of recurrent adenomas in patients who had experienced advanced CRC [RR 0.34, 95% CI 0.14 - 0.83, P 0.05]; Trial Sequential Analysis reveals that the combination therapy of DFMO effectively diminishes the occurrence of recurrent adenomas in patients with a history of advanced colorectal tumors, displaying a Risk Ratio (RR) of 0.33 with a 95% Confidence Interval (CI) of 0.12 - 0.90 and a significance level of P < 0.05. This combination exhibits a statistically significant difference. Subgroup analysis demonstrates that, depending on the drug treatment regimen (DFMO+ Aspirin/DFMO+ Sulindac), the combination of DFMO and aspirin exhibits an effect comparable to a placebo in diminishing the occurrence of new adenomas in patients with a history of advanced colorectal tumors. However, the combination of DFMO and sulindac significantly mitigates the incidence of recurrent adenomas in this patient population. Conclusion: This meta-analysis indicates that the existing randomized controlled trials are adequate to ascertain the efficacy of DFMO combination therapy in diminishing the incidence of recurrent adenomas in patients who have previously encountered advanced colorectal tumors. However, further clinical trials need to be conducted to evaluate the optimum dosage and treatment course of prophylactic implementation of DFMO combination therapy in high-risk populations.
Abstract licence: CC BY 4.0
Ambar Godoy, Daniela M. Montalvan-Sanchez, F. Príncipe-Meneses, et al.
Gastroenterology Research, 2025
Background Gastrointestinal (GI) tract malignancies represent a significant global health burden, being major contributors to cancer-related morbidity and mortality globally, with over 7.7 million cases reported. While aspirin is a well-studied chemopreventive agent for GI neoplasms, its use may be limited due to the underlying bleeding risk. Eflornithine (DFMO) is an inhibitor of the ornithine decarboxylase (ODC) which inhibits polyamine synthesis, and has shown promise as an alternative chemopreventive agent, particularly in animal studies and limited clinical trials. Methods Following PRISMA guidelines, we conducted a systematic review of studies evaluating DFMO alone or in combination for chemoprevention in premalignant GI lesions including chronic gastritis, atrophic gastritis, intestinal metaplasia, and dysplasia. The protocol was registered in Prospero (CRD42022309307). Randomized controlled trials (RCTs) and cohort studies in English or Spanish were included. Results Nine studies (six RCTs and three phase I-II trials) met inclusion criteria. Phase I-II trials involving Barrett’s esophagus and gastric cancer did not report significant benefits. Phase III-IV trials combining DFMO with nonsteroidal anti-inflammatory drugs (NSAIDs) were associated with reductions in adenoma recurrence, size, and polyamine levels in high-risk GI cancer populations. Side effects included ototoxicity, reversible upon discontinuation, and mild GI events, both occurring at higher doses. Conclusion While aspirin remains a frontline chemopreventive agent for GI neoplasms, this review shows that phase III-IV trials suggest promising outcomes in combination with NSAIDs, warranting further investigation. Notably, DFMO’s low cost and favorable toxicity profile may position it as a viable alternative, emphasizing the need for additional RCTs to delineate its efficacy and safety in GI cancer prevention. Further investigation into DFMO’s optimal dosage, duration, and side effect management is essential to establish it as a safe and effective chemopreventive agent.
Abstract licence: CC BY-NC
G. Priotto, S. Kasparian, D. Ngouama, et al.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2007
- Eflornithine
- Congo
- Nifurtimox
C. Burri, Reto Brun
Parasitology Research, 2003
- Eflornithine
- Trypanocidal Agents
- Trypanosoma brucei gambiense
Jessica Hidalgo, Raghavendra Tirupathi, Juan Fernando Ortiz, et al.
Open Forum Infectious Diseases, 2021
Abstract Background Sleeping sickness is an infectious disease transmitted mainly by the Trypanosoma Brucei, with the tsetse fly as a vector. The condition has two stages: The hemolymphatic and the meningo-encephalitic stage. The second stage is caused mainly by the Trypanosoma Brucei Gambiense. The treatment of the second stage has changed from melarsoprol, eflornithine, to now nifurtimox-eflornithine (NECT). This systematic review will focus on the efficacy and the toxicity of the medication. Methods We use PRISMA and MOOSE protocol for this review. On figure 1, we detail the methodology used for the extraction of information from the systematic review. To assess the study's bias, we used Cochrane Collaboration’s tool for risk assessment of the clinical trials and the Robins I tool for the observational studies. Results We collected four clinical trials and two observational studies after an extensive search. Three clinical trials showed that NECT was non-inferior to eflornithine with the following cure rates (NECT VS eflornithine): 1) 96.3% vs. 94.1% ; 2) 90.9% vs. 88.9%; 3) 91.6% vs. 96.5%. An additional clinical trial revealed that the proportion of patient discharge from the hospital was 98.4% (619/629); 95% CI [97.1%; 99.1%]). The two observational studies discussed the pharmacovigilance of the drug and toxicity related to NECT. In one study, patients treated with NECT, 589 (86%) experienced at least one adverse effect (AE) during treatment, and 70 (10.2%) experience serious AE. On average, children experienced fewer AEs than adults. In the other study at least one AE was described in 1043 patients (60.1%), and Serious AE was reported in 19 patients (1.1% of treated), leading to nine deaths (case fatality rate of 0.5%). The major limitations of the studies were the lack of blinding because most of them were open-label. Also, there was heterogenicity in the definition of the outcomes in the observational studies. PRISMA Flow Chart Conclusion NECT is not inferior to eflornithine, and the proportion of patients discharged from the hospital alive showed favorable results. The observational studies revealed a high frequency of AE. However, NECT is more convenient and safe than Eflornithine and Melarsoprol. Disclosures All Authors: No reported disclosures
Abstract licence: CC BY 4.0
E. Montalvan-Sanchez, Renato Beas, Rawan Aljaras, et al.
Gastroenterology, 2022
Freddie Kansiime, Seraphine Adibaku, Charles Wamboga, et al.
Parasites & Vectors, 2018
- Eflornithine
Morgan DR, Dominguez RL, Norwood DA, et al.
2026
Nawaz MU, Baig MB, Shahid SM, et al.
2025
BackgroundIdiopathic facial hirsutism (IFH) exerts a measurable negative impact on psychosocial well-being, even in the absence of identifiable endocrine dysfunction. Although light-based epilation technologies offer durable hair reduction, treatment-resistant regrowth remains a clinical challenge. Adjunctive topical therapies that modulate follicular activity are under investigation to potentially enhance and prolong the efficacy of such interventions.ObjectiveThe objective of this study is to compare the efficacy and tolerability of six-month sessions of intense pulsed light (IPL) combined with a topical agent versus the same IPL protocol alone in Pakistani women with IFH.MethodsIn this open-label randomised controlled trial, 152 women aged 18-70 years were randomised 1:1 to combination therapy (n = 76) or IPL alone (n = 76). The primary outcome was the proportion of participants achieving ≥ 1‑grade reduction on the modified Ferriman-Gallwey (mFG) scale at week 24. Secondary outcomes included mean percentage terminal-hair reduction and patient satisfaction.ResultsBaseline characteristics were comparable. At week 24, 89.5 % of the combination group met the primary endpoint compared with 69.7 % receiving IPL alone (absolute risk difference 19.8 %, p = 0.003). Mean terminal-hair reduction was 90 % versus 59 % (p ConclusionAdding a topical agent to IPL significantly improves clinical and patient-reported outcomes in IFH without increasing toxicity. The regimen may offer a practical, hormone-free first-line strategy for South-Asian women seeking rapid, durable cosmetic benefits.
Abstract licence: CC BY
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
3.5 hours
Mechanism
Eflornithine is an irreversible inhibitor of the enzyme ornithine decarboxylase…
Food interactions
1 warning
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3.5 hours
Half-life
3.5 hours
Protein binding
[L49288]
Volume of distribution
24.3 L
[L49288]
Metabolism
[L49298]
Elimination
[L49298]
Clearance
5.3 L/h
[L49298]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
In 1960 and 2000, the FDA approved eflornithine under the brand names ORNIDYL and VANIQUA for the treatment of African trypanosomiasis and hirsutism, respectively, but has since been discontinued.[A262823][L49318] Subsequently, on December 14, 2023, the FDA approved eflornithine again but under the brand name IWILFIN as an oral maintenance therapy to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. This approval is based on positive results obtained from a multi-site, single-arm, externally controlled study of children with high-risk neuroblastoma, where a 52% reduction in the risk of relapse and a 68% reduction in the risk of death were observed.[L49313]
[L49288]
It was also previously indicated for the treatment of female hirsutism and African trypanosomiasis but has since been discontinued.
[L49318]
Known interactions with other medications. Always consult a healthcare professional.
Showing 38 of 38 interactions
Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
[L49298]
In a 2-year carcinogenicity study, once daily oral administration of eflornithine to female rats did not result in drug-related neoplasms at doses up to 600 mg/kg/day (10.5 times the human Cmax at the recommended clinical dose of 1152 ± 384 mg/m2).
[L49298]
Eflornithine was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay.
[L49298]
Dedicated fertility studies were not conducted with eflornithine.
[L49298]
Additionally, polyamines are also involved in keratin synthesis, and inhibition of polyamines can decrease the proliferation of hair matrix cells and thus inhibit the anagen phase of hair production.[A4113]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L49288]
The mean percutaneous absorption of eflornithine in women with unwanted facial hair, from a 13.9% w/w cream formulation, is < 1% of the radioactive dose, following either single or multiple doses under conditions of clinical use, that included shaving within 2 hours before radiolabeled dose application in addition to other forms of cutting or plucking and tweezing to remove facial hair.
Steady state was reached within four days of twice-daily application. Following twice-daily application of 0.5 g of the cream (total dose 1.0 g/day; 139 mg as anhydrous eflornithine hydrochloride), under conditions of clinical use in women with unwanted facial hair (n=10), the steady-state Cmax, Ctrough and AUC12hr were approximately 10 ng/mL, 5 ng/mL, and 92 ng hr/mL, respectively, expressed in terms of the anhydrous free base of eflornithine hydrochloride. At steady state, the dose-normalized peak concentrations (Cmax) and the extent of daily systemic exposure (AUC) of eflornithine following twice-daily application of 0.5 g of the cream (total dose 1.0 g/day) is estimated to be approximately 100- and 60-fold lower, respectively, when compared to 370 mg/day once-daily oral doses.
[L49298]
[L49298][L49298]
[L49288]
[L49288]
[L49298]
[L49298]
[L49298]
Proteins and enzymes this drug interacts with in the body
ATC P01CX03
ATC L01XX79
ATC D11AX16
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Eflornithine
Additional database identifiers
Drugs Product Database (DPD)
12187
ChemSpider
2902
BindingDB
50028197
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8109
GenAtlas
ODC1
GeneCards
ODC1
GenBank Gene Database
M16650
GenBank Protein Database
29893806
Guide to Pharmacology
1276
UniProt Accession
DCOR_HUMAN
DrugBank citations
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Structured knowledge from the free knowledge base
Linked open data from Wikidata (Q424751), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.