While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.

Start Date18 Jun 2024

Sponsor / Collaborator

Armauer Hansen Research Institute

[+2]

NCT06251739 / RecruitingEarly Phase 1IIT

Assessing Safety and Efficacy of Repurposed Oral Ivermectin in PKDL Treatment

Burden: Post-Kala-Azar Dermal Leishmaniasis (PKDL) commonly follows visceral leishmaniasis (VL) caused by Leishmania donovani. It is characterized by skin lesions in which parasites can be identified, in a patient who is otherwise fully recovered from VL or exposed to L. donovani (LD) infection. It occurs in the Indian subcontinent (mainly India and Bangladesh) as well as in Africa (mainly Sudan). It is now established that PKDL patients play an important role in transmission of LD parasite where chronic PKDL patients have been implicated in major VL outbreaks in the past. Though VL cases are in decline due to extensive programmes conducted by NKEP, PKDL cases are in the rise and VL:PKDL ratio has risen from 1:0.47 to 1:1.21 from 2016 to 2020. In this current situation, elimination of PKDL cases is of crucial importance in the current VL elimination efforts in Bangladesh as well as in the Indian subcontinent.
Knowledge gap: Currently there are no satisfactory treatments for any forms of PKDL. Both miltefosine and Ambisome® as monotherapy have shown to be effective. However, with the current recommended scheme there are some drawbacks such as the length of the treatment with miltefosine alone (8-12 weeks), toxicity related to it; a high dose Ambisome® (total dose of 20 mg/kg) given frequently in 4 divided dosage often causes adverse events (e.g. pancytopania, hypokalemia, increased creatinine level etc.). There is also the potential risk for development of resistance with miltefosine as monotherapy. Ivermectin has been proven to have a significant leishmanicidal effect by several experimental studies at higher doses without significant toxicity and may offer shorter duration of treatment thus preventing prolonged hospitalization. Another possible advantage is reduction of cost. These principles can be applied to PKDL, where the need for an ambulatory treatment with a highly safe, efficacious and user friendly regimen is even more pressing as the patients feel otherwise healthy, except for the rashes.
Relevance: This study aims primarily to improve current treatment options. In addition, this will be the first human study ever in PKDL in relation to Ivermectin, in which outcome will be described in clinical, parasitological and immunological terms. Ultimately this study findings will help National Kala-Azar Elimination Program (NKAEP) to adopt specific strategies for elimination of PKDL cases.
Hypothesis (if any): Oral ivermectin in multiple doses is safe and more effective than Miltefosine for the treatment of PKDL cases.
Objectives: To measure the safety and efficacy of Ivermectin monotherapy regimen (60 mg oral on five consecutive days, for three consecutive months) in comparison to oral Miltefosine allometric dose for twelve weeks, for treating PKDL patients in Bangladesh.
Methods: This will be a comparative, open label, non-blinded, individually randomized, proof-of-concept Clinical Trial to assess the safety and efficacy of oral Ivermectin monotherapy (5 x 12 mg daily at a total dose of 60 mg per month for three consecutive months, 180 mg in total) and Miltefosine monotherapy (50 mg twice daily for 12 weeks) in treating PKDL patients in Bangladesh. All participants will be recruited at SKKRC, Mymensingh with due consent. All patients will be followed up for 12 months. Cure assessment will be performed.
Outcome measures/variables: Safety and efficacy of Ivermectin for PKDL treatment will be determined.

Start Date30 Oct 2023

Sponsor / Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

100 Clinical Results associated with Miltefosine

100 Translational Medicine associated with Miltefosine

100 Patents (Medical) associated with Miltefosine

2,487

Literatures (Medical) associated with Miltefosine

01 Jan 2025·Journal of Ethnopharmacology

Lantana camara L. induces a multi-targeted cell death process in Leishmania amazonensis

Article

Author: Campos, Lara Melo ; Fabri, Rodrigo Luiz ; Antinarelli, Luciana Maria Ribeiro ; Silva Neto, Adolfo Firmino da ; Midlej, Victor do Valle ; Bastos, João Pedro Reis Costa ; Machado, Patrícia de Almeida ; Lemos, Ari Sérgio de Oliveira ; Coimbra, Elaine Soares ; Granato, Juliana da Trindade

ETNOPHARMACOLOGICAL RELEVANCELantana camara L. is a species known for its broad spectrum of bioactivities and is commonly used in folk therapy to address inflammatory, dermatological, gastrointestinal, intestinal worms and protozoan diseases. It boasts a diverse array of secondary metabolites such as terpenes, flavonoids, and saponins. However, despite its rich chemical profile, there remains a scarcity of studies investigating its antileishmanial properties.AIM OF THE STUDYThis research aims to explore the antileishmanial potential of L. camara, focusing also on its mechanism of action against Leishmania amazonensis.MATERIAL AND METHODSThe ethanolic extract of L. camara leaves (LCE) was obtained through static maceration, and its phytoconstituents were identified using UFLC-QTOF-MS. The colorimetric MTT method was conducted to determine the effect of LCE on promastigotes of L. amazonensis and murine macrophages. The anti-amastigote activity was evaluated by counting intracellular parasites in macrophages after Giemsa staining. Additionally, investigations into the mechanisms underlying its action were conducted using cellular and biochemical approaches.RESULTSLCE exhibited significant activity against both promastigotes and intracellular amastigotes of L. amazonensis, with IC₅₀ values of 12.20 μg/mL ± 0.12 and 7.09 μg/mL ± 1.24, respectively. These IC₅₀ values indicate very promising antileishmanial activity, comparable to those found for the positive control miltefosine (5.10 μg/mL ± 1.79 and 8.96 μg/mL ± 0.50, respectively). Notably, LCE exhibited negligible cytotoxicity on macrophages (IC₅₀ = 223.40 μg/mL ± 47.02), demonstrating selectivity towards host cells (SI = 31.50). The antileishmanial activity of LCE involved a multi-targeted cell death process, characterized by morphological and ultrastructural alterations observed through SEM and TEM analyses, as well as oxidative effects evidenced by the inhibition of trypanothione reductase, elevation of ROS and lipid levels, and mitochondrial dysfunction evaluated using DTNB, H₂DCFDA, Nile red, and JC-1 assays. Additionally, extraction of ergosterol and double labeling with annexin V and PI revealed modifications to the organization and permeability of the treated parasite's plasma membrane. LCE was found to consist predominantly of terpenes, with lantadenes A, B, and C being among the eleven compounds identified through UFLC-QTOF-MS analysis.CONCLUSIONSThe extract of L. camara presents a diverse array of chemical constituents, prominently featuring high terpene content, which may underlie its antileishmanial properties through a combination of apoptotic and non-apoptotic mechanisms of cell death induced by LCE. This study underscores the therapeutic potential of L. camara as a candidate for antileishmanial treatment, pending further validation.

01 Dec 2024·Molecular Biology Reports

Hypoxia preconditioning increases Notch1 activity by regulating DNA methylation in vitro and in vivo

Article

Author: Sun, Kai ; Liu, Qi ; Xie, Yabin ; Xu, Wenqiang ; Fan, Peijia ; Zhang, Chunyang ; Chang, Zhehan ; Shao, Guo ; Gong, Kerui ; Zhao, Zhijun

BACKGROUNDOur previous research has demonstrated that hypoxic preconditioning (HPC) can improve spatial learning and memory abilities in adult mice. Adult hippocampal neurogenesis has been associated with learning and memory. The Neurogenic locus notch homolog protein (Notch) was involved in adult hippocampal neurogenesis, as well as in learning and memory. It is currently unclear whether the Notch pathway regulates hippocampal neuroregeneration by modifying the DNA methylation status of the Notch gene following HPC.METHODThe HPC animal model and cell model were established through repeated hypoxia exposure using mice and the mouse hippocampal neuronal cell line HT22. Step-down test was conducted on HPC mice. Real-time PCR and Western blot analysis were used to assess the mRNA and protein expression levels of Notch1 and hairy and enhancer of split1 (HES1). The presence of BrdU-positive cells and Notch1 expression in the hippocampal dental gyrus (DG) were examined with confocal microscopy. The methylation status of the Notch1 was analyzed using methylation-specific PCR (MS-PCR). HT22 cells were employed to elucidate the impact of HPC on Notch1 in vitro.RESULTSHPC significantly improved the step-down test performance of mice with elevated levels of mRNA and protein expression of Notch1 and HES1 (P < 0.05). The intensities of the Notch1 signal in the control group, the H group and the HPC group were 2.62 ± 0.57 × 10⁷, 2.87 ± 0.84 × 10⁷, and 3.32 ± 0.14 × 10⁷, respectively, and the number of BrdU (+) cells in the hippocampal DG were 1.83 ± 0.54, 3.71 ± 0.64, and 7.29 ± 0.68 respectively. Compared with that in C and H group, the intensity of the Notch1 signal and the number of BrdU (+) cells increased significantly in HPC group (P < 0.05). The methylation levels of the Notch1 promoter 0.82 ± 0.03, 0.65 ± 0.03, and 0.60 ± 0.02 in the C, H, and HPC groups, respectively. The methylation levels of Notch1 decreased significantly (P < 0.05). The effect of HPC on HT22 cells exhibited similarities to that observed in the hippocampus.CONCLUSIONHPC may confer neuroprotection by activating the Notch1 signaling pathway and regulating its methylation level, resulting in the regeneration of hippocampal neurons.

01 Nov 2024·Journal of Biomolecular Structure and Dynamics

Thiadiazine-thiones as inhibitors of leishmania pteridine reductase (PTR1) target: investigations and in silico approach

Article

Author: Shtaiwi, Amneh

Leishmaniasis is a widespread parasitic disease and is one of the major public health concerns in developing countries. Many drugs have been identified for leishmania as targets, but the potential toxicity and long-term treatment remain the most significant problems in terms of further development. The present study employed physicochemical investigations, structure-based virtual screening, ADMET analysis, molecular dynamics simulation, and MM-PBSA, to identify potential compounds for Leishmania. We evaluated 30,926 natural products from the NPASS database, and four potentials passed the pharmacokinetic ADMET studies and were verified using the molecular docking approach. Molecular docking results showed good binding interaction of the compounds with the active site of leishmania pteridine reductase enzyme PTR1, with compound TTC1 showing FRED and Autodock binding energies of -10.33 and -10.94, respectively, which were comparable with the antileishmania drugs of Allopurinol, Miltefosine and the original ligand, methotrexate. TTC1 compound was found to be favorable for hydrophobic interaction with PTR1. In addition, the physicochemical properties of the compounds were studied using the SwissADME web server. All compounds followed Lipinski's rule of five and can be considered as good oral candidates. The analysis of the 100 ns molecular dynamics simulation results based on the best-docked TTC1 with PTR1 receptor demonstrates stable interactions, and the complex undergoes low conformational fluctuations. The average of the calculated binding free energy of the TTC1-1e7w complex is (-68.67 kJ/mol), and the result demonstrated that the TTC1 promoted stability to the Leishmania-PTR1 complex. The potential compounds can be further explored for their antileishmanial activity.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Miltefosine

26 Apr 2023

·www.biospace.com

60 Degrees Pharmaceuticals Awarded U.S. Patent Covering Tafenoquine for Treatment of COVID-19 and Other Lung Infections

Patent provides exclusive use through 2040 of tafenoquine for treatment of COVID-19 and other lung infections. Tafenoquine is the active molecule in 60P’s FDA-approved drug for malaria prevention, ARAKODA®. Data from a Phase II study completed last year suggest a positive therapeutic signal in mild-moderate COVID-19 disease using the ARAKODA regimen of tafenoquine. Later this year the Company will launch a Phase IIB study enrolling COVID-19 patients in 30 U.S. outpatient clinics. 60P expects Phase IIB study will demonstrate ARAKODA regimen of tafenoquine accelerates time to sustained clinical recovery from COVID-19 symptoms. WASHINGTON, April 26, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals (“60P”), specialists in developing and marketing medicines for infectious diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the use of tafenoquine as a treatment for COVID-19 disease. Tafenoquine is the active molecule in the Company’s FDA-approved regimen for malaria prevention, ARAKODA®. 60P now owns the exclusive rights for the use of tafenoquine for treatment of viral lung infections including COVID-19 in the U.S. through 2040. ARAKODA, an oral tablet containing 100 mg of a tafenoquine base, is indicated for the prophylaxis of malaria in patients aged 18 years and older for up to 6 months of continuous dosing in the U.S. ARAKODA is not currently FDA-approved for the treatment of symptoms caused by the COVID-19 virus. 60P plans to conduct a double-blind, randomized, placebo-controlled Phase IIB trial to study the efficacy of the ARAKODA regimen of tafenoquine in COVID-19 patients with mild-moderate symptoms and low risk of disease progression. The primary endpoint of the Phase IIB study will be time to sustained clinical recovery from COVID-19 symptoms. The study will enroll patients in 30 out-patient clinics across the U.S. The Company is also planning a larger study that will commence in 2024. Data from a Phase II study published in New Microbes and New Infections, Vol. 47, April – May 2022, a peer-reviewed, open-access journal, suggested a positive therapeutic signal in mild-moderate COVID-19 disease using the ARAKODA regimen of tafenoquine; the time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm. Public health interest in combating COVID-19 remains high. Currently marketed FDA-approved oral COVID-19 therapeutics are not appropriate for use by at least 25 percent of the U.S. population who do not have risk factors for progression to severe disease or by travelers who may wish to protect themselves from COVID-19 for extended periods – an unaddressed multi-billion-dollar market opportunity. 60P is optimistic that the ARAKODA regimen of tafenoquine will play an important role in public health efforts to address gaps in the standard of care for COVID-19. About the ARAKODA® Regimen of Tafenoquine for COVID-19 Clinical trial data suggesting the ARAKODA® regimen of tafenoquine exhibits a positive therapeutic signal in mild-moderate COVID-19 disease were published last year in New Microbes and New Infections, Vol. 47, April – May 2022, a peer-reviewed, open-access journal. The drug increased the proportion of clinically recovered patients by between 9 percent (intent to treat population) and 14 percent (per protocol population); the drug decreased the proportion of clinically unrecovered patients by between 27 percent (intent to treat population) and 47 percent (per protocol population) but was underpowered to show statistical significance for the primary endpoint due to early termination of the study at n=86 patients. Results also showed that time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm of the double-blind, randomized, placebo-controlled Phase II study. About ARAKODA® (tafenoquine) Tafenoquine was discovered by Walter Reed Army Institute of Research and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. It has been shown that tafenoquine inhibits SARS-CoV-2 replication in monkey kidney and human epithelial cells, and pharmacokinetic simulations suggest lung levels at the FDA-approved dose for malaria prevention may exceed the EC90 of the drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA is not suitable for everyone and patients and prescribers should review the Important Safety Information below. ARAKODA® (tafenoquine) Important Safety Information ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. Important Safety Information Contraindications ARAKODA should not be administered to: Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown Patients with a history of psychotic disorders or current psychotic symptoms Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA Warnings and Precautions Warnings and Precautions Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. G6PD Deficiency in Pregnancy or Lactation:ARAKODA may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Check infant’s G6PD status before breastfeeding begins. Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA therapy and evaluation by a mental health professional as soon as possible. Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA. If hypersensitivity reactions occur, institute appropriate therapy. Delayed Adverse Reactions: Due to the long half-life of ARAKODA, (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration. Adverse Reactions The most common adverse reactions (incidence ≥1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety. Drug Interactions Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. Use in Specific Populations Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or ARAKODA full prescribing information is here. About 60 Degree Pharmaceuticals, Inc. 60 Degrees Pharmaceuticals, Inc., founded in 2010, focuses on discovering, developing and distributing new medicines for the treatment and prevention of tropical diseases, including malaria and dengue. 60P’s mission is supported through in-kind funding from the United States Department of Defense. The Company also collaborates with prominent research organizations in the U.S., Australia and Singapore. In addition, 60P has been funded by Knight Therapeutics Inc., a Canadian specialty pharmaceutical company that obtained FDA approval for Impavido, a product for leishmaniasis, a tropical disease, and monetized a PRV. 60P is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at . Forward-Looking Statements The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. The statements expressed herein are those of 60P and do not necessarily represent those of the United States Department of Defense or the Department of the United States Army. Forward-looking terminology, such as “may,” “will,” “should,” “expect,” “anticipate,” “project,” “estimate,” “intend,” “continue” or “believe” or the negatives thereof, or other variations thereon or comparable terminology, may discuss our plans, strategies, prospects and expectations concerning our business, operating results, financial condition and other similar matters. However, we are not able to predict accurately or control these matters. Any forward-looking statement made by us in this press release speaks only as of the date on which we make it. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Media Contact: Sheila A. Burke Method Health Communications methodhealthcomms@gmail.com 484-667-6330

Phase 2Clinical ResultDrug ApprovalPhase 3

01 Dec 2022

·www.sciencedaily.com

Step closer to tackling drug resistant parasites in Brazil

Researchers are a step closer to identifying ways to support clinicians in predicting drug treatment outcomes for patients with visceral leishmaniasis in Brazil. Researchers at the University of York are a step closer to identifying ways to support clinicians in predicting drug treatment outcomes for patients with visceral leishmaniasis in Brazil. Scientists at York had previously shown that the absence of four particular genes in some strains of Leishmania infantum parasite found in Brazil makes it less susceptible to an oral drug called miltefosine. The absence of these genes correlates with resistance to the drug, which means that Brazilian patients would benefit from a prognostic test, but in order to do this scientists first had to identify what it was about the gene that made the parasite drug-resistant. During a clinical trial using miltefosine treatment, 40% of patients relapsed within six months, but the presence of the genes in the parasite found in India, however, meant that after a month of treatment, the disease could be cured with a lower risk of relapse. As a result of its 'failure' in Brazil the medication is not licensed in the country and therefore there is very little that can be done to manage the disease in patients, other than intravenous drugs which can prove to be a burden on medical facilities who have to deliver it. The team, in collaboration with colleagues from the Universidade Federal do Piauí and and the Universidade Federal do Espírito Santo, have now taken the work a step further and identified the enzymes that make the difference between treatment success and failure. Juliana Brambilla Carnielli, Research Associate at the University of York's Department of Biology, said: "Now that we have narrowed the search from a set of genes to an enzyme, the potential for developing a blood test that can accurately predict patient outcome is more likely. "There is no one-size-fits all treatment, and so a personalised medicines approach is needed, whereby a prognostic test to predict treatment success at an individual level can be provided. "This disease impacts people in India, Brazil, Africa and some parts of Europe, so it really is important that we understand more about how the parasite lives in humans and reacts to drugs." Leishmaniasis is a parasitic disease transmitted to humans by the bite of the infected female sandfly. With 50,000 to 90,000 new cases worldwide each year, it causes fever, substantial weight loss, swelling of the spleen and liver and anemia and can be fatal if left untreated. The parasite first arrived in South America from Europe in the 1600s and has changed and adapted over time, Jeremy Mottram, Professor of Pathogen Biology and Director of the York Biomedical Research Institute, said: "This latest finding means that we are much closer to moving to clinical trials on patients in Brazil and to understand whether prognostic tests early in the disease progression and tailored medicines could reduce the numbers of patients relapsing with the disease." Up to 2,500 patients presented with the condition in Brazil in 2019 with a lethality rate of 9%, the highest recorded over the last 10 years, creating a significant burden on hospital resources. The research is funded by an MRC GCRF Foundation Award, MRC GCRF 'A Global Network for Neglected Tropical Diseases', and the Fundação de Pesquisa do Estado do Espírito Santo -- FAPES, Brazil, and is published in the journal eBioMedicine.

Clinical Study

100 Deals associated with Miltefosine

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KEGG	Wiki	ATC	Drug Bank
D02494	Miltefosine	P01CX04	DB09031

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Leishmaniasis, Mucocutaneous	US	Knight Therapeutics (USA), Inc.	19 Mar 2014
Leishmaniasis, Visceral	US	Knight Therapeutics (USA), Inc.	19 Mar 2014

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCD2023	Not Applicable	Leishmaniasis	6	Miltefosine	(zmeyvaddfh) = vcoledbuca xgnlqqxjfb (vqjwhfysnz ) View more	Positive	03 Jul 2023
NCT03129646 (Pubmed)	Phase 3	Leishmaniasis, Visceral	439	Paromomycin plus Miltefosine	qvcwzldble(trgheyeamd) = tysjvlouvp wbtcevsppc (lhecrqihbh, -6.2 to 7.4)	Positive	27 Sep 2022
				Sodium Stibogluconate plus Paromomycin	qvcwzldble(trgheyeamd) = eggqqnaqyz wbtcevsppc (lhecrqihbh, -6.2 to 7.4)
NCT02687971 (Pubmed \| PLoS Negl Trop Dis)	Phase 2	Leishmaniasis, Cutaneous	130	Thermotherapy	(hipxgdgahg) = The presence of vesicles at the site of heat application was the most common adverse event reported associated with the use of TT; while vomiting (31.8%) and elevation of liver enzymes (28.8%) were the most frequent adverse events reported associated with the use of MLT. zzcbxncytl (mbpzhbothr )	Positive	07 Mar 2022
				Thermotherapy + Miltefosine
NCT01050907 (CTgov)	Phase 2	Leishmaniasis, Mucocutaneous	4	Miltefosine	unaunsngft(ljqfdmgwnp) = lawmrpmnei ygpmbacdpl (fqffrnjylk, ceymfoozcx - lxmmwymipf) View more	-	30 Sep 2020
NCT02431143 (Pubmed \| Clin Infect Dis)	Phase 2	Leishmaniasis, Visceral	30	Allometric Miltefosine	(mzwskvyuiq) = There were 2 serious AEs: both were unrelated to treatment and both patients were fully recovered qbqvclattg (qafuriddgb ) View more	-	24 Apr 2019
NCT01122771 (Pubmed \| PLoS Negl Trop Dis)	Phase 3	Leishmaniasis, Visceral	601	AmBisome monotherapy	(zxlebapznv) = There were 12 serious adverse events in the study in 11 patients that included 3 non-study drug related deaths. There were no relapses or PKDL up to 6 months follow-up. All treatments were well tolerated with no unexpected side effects. Adverse events were most frequent during treatment with miltefosine + paromomycin, three serious adverse events related to the treatment occurred in this arm, all of which resolved. zvoxhgrbbi (iezdgpjvfu )	-	01 May 2017
				AmBisome + paromomycin
NCT01462500 \| NCT00487253 \| NCT01464242 (Pubmed \| PLoS Negl Trop Dis)	Not Applicable	Leishmaniasis, Cutaneous	-	miltefosine	kogskgeppc(hvdkzeklbw) = irjdtfksce fpixrcrwfe (jlnppdhxrs, 3.59 - 14.26)	-	01 Apr 2017
				meglumine antimoniate	kogskgeppc(hvdkzeklbw) = obnnstuace fpixrcrwfe (jlnppdhxrs, 14.48 - 29.58)
NCT01170949 (MIARCU, CTgov)	Phase 2	Chronic Urticaria	76	Miltefosine (Miltefosine)	(dragymwhzx) = jfthzeebuh kdfnjydpnp (nffszzuhgi, kkhfkhunju - ubnjiebgqs) View more	-	26 Dec 2016
				Placebo (Placebo)	(dragymwhzx) = knleovkcbv kdfnjydpnp (nffszzuhgi, reonvmighz - oxftrtxarf) View more
NCT01067443 (Pubmed \| PLoS Negl Trop Dis)	Phase 2	Leishmaniasis, Visceral	151	AmBisome + SSG	(grrdmkzczs) = doptjpiixr djeqnlalui (zwxnoucfik, 73 - 92) View more	-	01 Sep 2016
				AmBisome + miltefosine	(grrdmkzczs) = ysvykmproj djeqnlalui (zwxnoucfik, 73 - 92) View more
NCT00471705 (Pubmed \| Rev Inst Med Trop Sao Paulo)	Phase 3	Leishmaniasis, Cutaneous	437	Miltefosine	(ntwdiqhdtl) = The adverse effects were primarily gastrointestinal for miltefosine and pain at the lesion site after treatment for thermotherapy uzdgjmmqld (xizmdmdrro )	Positive	01 Jan 2013
				Thermotherapy

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