Delving into the Latest Updates on Ivermectin with Synapse

Overview

Basic Info

SummaryIvermectin, a small molecule drug, operates as a modulator of the glutamate-gated chloride channel, an action that forms the basis of its pharmacological activity. The drug was granted approval by the FDA in November 1996, and its development can be attributed to the remarkable efforts of Merck Sharp & Dohme Corp. Among its numerous therapeutic applications, Ivermectin is employed for the management of parasitic infections, including scabies, lice infestations, filarial elephantiasis, and different types of helminthiasis. Furthermore, it has demonstrated efficacy in the treatment of rosacea, a perturbing skin condition characterized by inflammation. Ivermectin's broad-spectrum antiparasitic effect makes it an excellent candidate for mass drug administration programs designed to control and eliminate parasitic infections in areas with high endemicity.

Drug Type

Small molecule drug

Synonyms

mdc-STM, CD-5024, K-237

+ [13]

Target

GluCls

Mechanism

Glutamate-gated chloride channel modulators

Therapeutic Areas

Infectious DiseasesHemic and Lymphatic DiseasesSkin and Musculoskeletal Diseases+ [2]

Active Indication

RosaceaLice InfestationsScabies+ [9]

Inactive Indication

Acne VulgarisDermatitis, AtopicPediculus capitis infestation

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Merck Sharp & Dohme Corp.

MedinCell SA

+ [7]

Inactive Organization

Galderma Holding SAGalderma Research & Development SNCTaro Pharmaceuticals U.S.A., Inc.

Drug Highest PhaseApproved

First Approval Date

US (22 Nov 1996),

OnchocerciasisStrongyloidiasis

RegulationOrphan Drug (JP)

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Structure

Molecular FormulaC47H72O14

InChIKeyVARHUCVRRNANBD-PVVXTEPVSA-N

CAS Registry70209-81-3

This is an open label prospective pharmacokinetic single arm study in Laos PDR. This study will be embedded within a cluster-randomized controlled trial of interventions to address childhood undernutrition (SUANHOAM Trial, ACTRN12620000520932) and involves a collaboration with the Murdoch Children's Research Institute, Burnet institute and Lao Tropical and Public Health Institute.
ITCHY Study:
The primary objective is to determine in young children aged 2 to <5 years and weighing 10 to <15 kg if an ivermectin dose of 3 mg achieves comparable drug exposures to the recommended dose in older children. It aims to provide reliable evidence for a safe and effective dose of ivermectin in young children who are especially vulnerable to scabies infections and the associated secondary complications.
ITCHY2 Study:
An embedded phase 2 multicentre, open label prospective pharmacokinetic study in Laos PDR of ITCHY Study. The primary objective is to determine the plasma ivermectin drug exposure in children aged 3 months to 2 years and weighing ≥2 kg receiving an age specific ivermectin dose.

Start Date01 Oct 2024

Sponsor / Collaborator

Murdoch Childrens Research Institute

[+1]

NCT06404333 / Not yet recruitingPhase 2IIT

A Randomized Trial to Assess the Safety, Pharmacokinetics, Acceptability, and Efficacy of Pediatric Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms

The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy

Start Date01 Oct 2024

Sponsor / Collaborator

University of Oxford

[+2]

100 Clinical Results associated with Ivermectin

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100 Translational Medicine associated with Ivermectin

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100 Patents (Medical) associated with Ivermectin

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7,370

Literatures (Medical) associated with Ivermectin

01 Jan 2025·VETERINARY PARASITOLOGY

Role of autophagy in resistance to ivermectin in Haemonchus contortus

Article

Author: Du, Jun ; Liu, Yang ; Luo, Xiaoping ; Zhai, Bintao ; Li, Junyan ; Li, Anben ; Yang, Xiaoye ; Fu, Nana ; Zhou, Xuezhang

Haemonchus contortus is a highly pathogenic gastrointestinal nematode that parasitizes the abomasum of cattle, sheep, and other ruminants. Long-term use of large quantities of ivermectin (IVM) to control H. contortus has resulted in the development of drug resistance. However, the mechanism of IVM resistance in H. contortus remains incompletely understood. Autophagy is involved in regulating drug resistance in some parasites. Previous omics sequencing of differentially expressed genes in drug-resistant strains of H. contortus revealed substantial enrichment of autophagy-related pathway. Therefore, autophagy was used as the entry point in this study to investigate its role in IVM resistance in H. contortus. Larval migration inhibition test, RT-qPCR, and transmission electron microscopy of IVM-susceptible and -resistant strains were performed. Results showed that the H. contortus-resistant strain had higher autophagy levels than the susceptible strain. After IVM treatment, the susceptible strain exhibited significant upregulation of the autophagy-related genes lgg-1, lgg-2, bec-1, lc3, and atg-18 and significant downregulation of the autophagy substrate sqst-1, along with an increased number of autolysosomes. Additionally, the autophagy inhibitor 3-MA reduced the resistance of the IVM-resistant H. contortus strain toward IVM after inhibiting autophagy, and the autophagy inducer urolithin A reduced the susceptibility of the IVM-susceptible H. contortus strain of IVM after activating its autophagy. These results demonstrate that IVM promotes autophagy in H. contortus and that autophagy is involved in regulating drug resistance in H. contortus. This study fills the knowledge gap regarding the role of autophagy in H. contortus drug resistance and provides a novel perspective on the study of drug resistance mechanisms in H. contortus.

01 Jan 2025·VETERINARY PARASITOLOGY

Ivermectin induces oxidative stress and mitochondrial damage in Haemonchus contortus

Article

Author: Li, Junyan ; Yuan, Jianqi ; Zhang, Xingfu ; Jin, Yamei ; Feng, Xingang ; Zhong, Haoran ; Gong, Gaowa ; Luo, Xiaoping ; Feng, Ying ; Gu, Cuifang

Haemonchus contortus poses a severe threat to livestock, leading to substantial economic losses. The extensive use of ivermectin (IVM), an effective anthelmintic drug, has resulted in the development of resistant strains, reducing the drug's effectiveness and making disease management more challenging. Hence, understanding the underlying mechanisms of IVM resistance is crucial. IVM has been shown to induce apoptosis and oxidative stress imbalance in cancer cells, thereby inhibiting tumor growth; however, whether there is a similar impact on H. contortus has not been well-documented. In this study, the biological functions of previously identified resistance-associated genes were investigated, revealing their involvement in apoptosis and oxidative stress. Experiments were conducted to compare cell apoptosis, mitochondrial function, and oxidative stress markers in IVM-treated and untreated sensitive and resistant strains isolated from the field. The findings demonstrated that mitochondrial dysfunction and increased apoptosis were induced by IVM treatment in sensitive strains, as indicated by elevated mitochondrial membrane potential and apoptosis rates. Conversely, stable mitochondrial function and apoptosis levels under IVM exposure were observed in resistant strains. These results provide novel insights into the resistance mechanisms of H. contortus and offer a theoretical basis for future research on overcoming IVM resistance.

31 Dec 2024·Global Public Health

Pharmaceutical messianism and the politics of COVID-19 in the United States

Article

Author: Lasco, Gideon ; Yu, Vincen Gregory ; Bharti, Nishtha

Throughout the COVID-19 pandemic, public officials in the United States - from the President to governors, mayors, lawmakers, and even school district commissioners - touted unproven treatments for COVID-19 alongside, and sometimes as opposed to, mask and vaccine mandates. Utilising the framework of 'pharmaceutical messianism', our article focuses on three such cures - hydroxychloroquine, ivermectin, and monoclonal antibodies - to explore how pharmaceuticals were mobilised within politicised pandemic discourses. Using the states of Utah, Texas, and Florida as illustrative examples, we make the case for paying attention to pharmaceutical messianism at the subnational and local levels, which can very well determine pandemic responses and outcomes in contexts such as the US where subnational governments have wide autonomy. Moreover, we argue that aside from the affordability of the treatments being studied and the heterodox knowledge claiming their efficacy, the widespread uptake of these cures was also informed by popular medical (including immunological) knowledge, pre-existing attitudes toward 'orthodox' measures like vaccines and masks, and mistrust toward authorities and institutions identified with the 'medical establishment'. Taken together, our case studies affirm the recurrent nature of pharmaceutical messianism in times of health crises - while also refining the concept and exposing its limitations.

76

News (Medical) associated with Ivermectin

26 Nov 2024

·www.businesswire.com

Dr. Reddy's Laboratories and Senores Pharmaceuticals, Inc. Announce the Launch of Ivermectin Tablets USP, 3 mg in US Market

HYDERABAD, India--( BUSINESS WIRE )--Dr. Reddy's Laboratories, Inc. and Senores Pharmaceuticals, Inc. today announced the launch of Ivermectin Tablets USP, 3 mg, which is bioequivalent and therapeutically equivalent to STROMECTOL® Tablets of Merck Sharp and Dohme LLC in the U.S. market. The product will be marketed by Dr. Reddy's. “We are pleased to advance our growth with the launch of a limited-competition product. With our continuous focus on niche opportunities, we are proud to be the second generic to receive approval for this product,” stated Swapnil Shah, Managing Director, Senores Pharmaceuticals Limited. Ivermectin Tablets, 3 mg brand and generic products, had U.S. sales of approximately $20 million MAT for the twelve months ending in September 2024 according to IQVIA. RDY-1124-747 About Dr. Reddy’s : Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com . About Senores Pharmaceuticals, Inc. : Senores Pharmaceuticals, Inc., based in Georgia, USA, is a wholly owned subsidiary of Senores Pharmaceuticals Limited and one of the fastest-growing pharmaceutical companies in the USA. The company has more than 25 products commercially launched or filed with the USFDA. For more information about Senores Pharmaceuticals, Inc., please visit www.senorespharma.com . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.

Drug Approval

14 Nov 2024

·endpts.com

Trump picks vaccine skeptic Kennedy to lead HHS, in what would be an upheaval of US health policy

President-elect Donald Trump has picked Robert F. Kennedy Jr. to be his next HHS secretary, likely giving the government’s most powerful healthcare post to a vaccine skeptic whose controversial views would be a huge break with decades of US health and scientific policies. “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation and disinformation when it comes to public health,” Trump said in a social media post announcing the selection. Kennedy is a longtime anti-vaccine crusader and environmental advocate who dropped out of the presidential race to endorse Trump in August. His “Make America Healthy Again” platform — a riff on Trump’s campaign slogan — emerged as a priority from various members of the former president’s camp, including Trump himself. HHS is a massive agency that oversees nearly $2 trillion in federal spending. Its sub-agencies include the governance of Medicare and Medicaid, drug and food regulation at the FDA, the sprawling scientific work of the NIH, and numerous other bodies overseeing everything from public health to biodefense. Last month, Kennedy gave a preview of what his leadership of the agency would mean. In a post on X, he said that “FDA’s war on public health is about to end,” and calling for stopping what he called the suppression of “psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.” Biotech stocks fell on reports of the pick, with the Nasdaq Biotech Index declining 2.4% at the close. Shares of vaccine makers fell as well, with Moderna $MRNA dropping 5.6% after the news broke and Pfizer $PFE down 2.6%. Trump has promised to give Kennedy wide latitude on healthcare issues. “I’m gonna let him go wild on health,” Trump said at an October campaign event in Madison Square Garden in New York. “I’m gonna let him go wild on the food. I’m gonna let him go wild on the medicines.” A name mentioned as a possible FDA pick under a Kennedy HHS is Casey Means, a Stanford-trained physician-turned-wellness advocate who might prove to be almost as controversial as Kennedy. Means, like Kennedy, has raised questions about the safety of vaccines, implying a link to autism. Such a link has never been proven, and an older study that has been the basis of many of those claims has been retracted and debunked. In addition to Kennedy’s anti-vaccine views, he has threatened to eliminate portions of federal health agencies and push out or discipline staff. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” Kennedy said in the October post on X . He has also espoused a number of more mainstream positions, including calling for a focus on wellness and the prevention of chronic disease, overhauling regulations for direct-to-consumer pharmaceutical ads, having Americans pay no more than other developed nations for drugs, and eliminating many pollutants and additives from the food supply, according to an opinion piece he wrote for the Wall Street Journal in September . But many of those views have been overshadowed by Kennedy’s embrace of conspiracy theories, such as his apparent support for the idea that high-altitude airplane contrails are in fact a government program to disperse chemicals. (They are actually condensed water.) Those positions could make for a less-than-certain Senate confirmation process, since they would almost certainly include a thorough review of his many controversial positions that are at odds with much of the healthcare establishment, as well as a number of recent personal scandals . Kennedy would hardly be the only controversial choice for the Trump administration. This week, he said he had chosen former Rep. Matt Gaetz of Florida to be his attorney general . Gaetz has been the subject of an ethics complaint over allegations of sex trafficking, as well as a fierce Trump ally and critic of the Department of Justice. Editor’s note: This story has been updated throughout with new details.

VaccineExecutive Change

14 Nov 2024

·www.adalvo.com

Adalvo announces successful DCP Submission for Ivermectin topical cream

Adalvo is pleased to announce the successful EU DCP Submission for Ivermectin 10mg/g topical cream. Our Ivermectin cream is being developed in collaboration with one of our strategic partners, based on the reference brand Soolantra, Galderma. The product is used on the skin to treat pimples and spots found with rosacea. According to IQVIA, the INN with strength 1%(10mg/g) generated approximately $214mn in global sales in 2022. With our clearly defined product pathway, we believe Adalvo will be amongst the first wave of filers, and will be ready to launch on Day-1 in all major markets. As a company committed to our dermatology portfolio, we offer an array of dossiers and aim to assist our partners in overcoming any challenges that may arise with these mature products. Our dermatology products include: Adapalene Gel Adapalene + Benzoyl Peroxide Gel Tacrolimus Ointment Dimetindene Gel

100 Deals associated with Ivermectin

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External Link

KEGG	Wiki	ATC	Drug Bank
D00804	Ivermectin	D11AX22 P02CF01	DB00602

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rosacea	US	Galderma Laboratories LP	19 Dec 2014
Lice Infestations	US	Arbor Pharmaceuticals LLC	07 Feb 2012
Scabies	JP	MSD KK	21 Aug 2006
Ascariasis	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	01 Jan 2001
Elephantiasis, Filarial	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	01 Jan 2001
Enterobiasis	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	01 Jan 2001
Helminthiasis	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	01 Jan 2001
Hookworm Infections	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	01 Jan 2001
Trichuriasis	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	01 Jan 2001
Onchocerciasis	US	Merck Sharp & Dohme Corp.	22 Nov 1996
Strongyloidiasis	US	Merck Sharp & Dohme Corp.	22 Nov 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	BG	MedinCell SA	25 Mar 2022
Dermatitis, Atopic	Phase 2	CA	Galderma Holding SA	01 Nov 2016
Dermatitis, Atopic	Phase 2	CA	Galderma Research & Development SNC	01 Nov 2016
Acne Vulgaris	Phase 2	CA	Galderma Holding SA	25 Apr 2016
Acne Vulgaris	Phase 2	CA	Galderma Research & Development SNC	25 Apr 2016
Acne Vulgaris	Phase 2	FR	Galderma Holding SA	25 Apr 2016
Acne Vulgaris	Phase 2	FR	Galderma Research & Development SNC	25 Apr 2016
Acne Vulgaris	Phase 2	DE	Galderma Research & Development SNC	25 Apr 2016
Acne Vulgaris	Phase 2	DE	Galderma Holding SA	25 Apr 2016
Pediculus capitis infestation	Phase 1	US	Taro Pharmaceuticals U.S.A., Inc.	20 Mar 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04848688 (StrongMoxi_KH, CTgov)	Phase 3	Strongyloidiasis	332	Placebo+Moxidectin 2 mg (Moxidectin)	qplnhzaxyw(xuyockdgxl) = ehmnpqvhza avrlgglsce (guxcpkaflu, whdirtmupq - odiuuujlkh) View more	-	24 Jan 2024
				Placebo+Ivermectin 3 mg (Ivermectin)	qplnhzaxyw(xuyockdgxl) = ucgcgdprxe avrlgglsce (guxcpkaflu, mnwhyjspjn - ptjuevwomt) View more
NCT03967054 (RIMDAMAL II, CTgov)	Phase 3	Malaria	4,124	Ivermectin (Ivermectin Mass Drug Administration)	rlwdjizqbl(mcjzhvkhym) = vcmaoikfyv ihbigxtmhu (ibcbkhpzhf, xqrbnguypo - cxemwnqkcm) View more	-	11 Jan 2024
				Placebo oral tablet (Placebo Mass Administration)	rlwdjizqbl(mcjzhvkhym) = bpkcycetuh ihbigxtmhu (ibcbkhpzhf, javhaauhil - vxrkddbbps) View more
NCT05894538 (CTgov)	Phase 3	COVID-19	1,459	Ivermectin (Arm D - Ivermectin 600)	rtjmdtxpvo(zwwwkmfunj) = gbfslnjxhb obknksraye (lqyhbolhbo, fnaqzrsshx - hijphvtiuj) View more	-	28 Sep 2023
				Placebo (Arm D - Placebo)	rtjmdtxpvo(zwwwkmfunj) = uuoigxnaox obknksraye (lqyhbolhbo, oqsphwlpec - iskshwzgye) View more
NCT04510194 (COVID-OUT, CTgov)	Phase 3	COVID-19	1,323	Metformin (Treatment Arm - Metformin Only Group)	ogfkgtciri(onabzbkjwa) = twmelwhcgl uocbxjgvtz (dwtuvwurhf, dngxlhskti - tqkvwotedr) View more	-	13 Jul 2023
				Placebo (Treatment Arm - Placebo Group)	ogfkgtciri(onabzbkjwa) = cdzmowxane uocbxjgvtz (dwtuvwurhf, srpclkbqxx - kqrwkcultc) View more
WCD2023	Not Applicable	Scabies	-	ivermectin (Community residents)	ptbmmvthed(mqpqskskgx) = dhrevwdgyb qwoiqawrzr (vwhzhypzeo )	-	06 Jul 2023
WCD2023	Not Applicable	Rosacea	-	Ivermectin 1% cream and doxycycline 40 mg	(zduazruuuk) = uycxymitiz hzottkmhdg (dgynxbqcsv )	-	03 Jul 2023
				Ivermectin 1% cream and Placebo	(zduazruuuk) = ezhrdqpkrv hzottkmhdg (dgynxbqcsv )
NCT03250624 (CTgov)	Phase 2	Dermatitis, Atopic	63	CD5024 0.3% cream (CD5024 0.3% Cream)	vjpaevyhnr(thmfxxcvij) = heyjjpdabd djndsjajdy (tbmikhvrjm, afodarvzar - vrafyemfel) View more	-	01 May 2023
				Placebo (Placebo)	vjpaevyhnr(thmfxxcvij) = ufqazlvohw djndsjajdy (tbmikhvrjm, eqihmtjgfq - caxmrlgiet) View more
NCT05736861 (CTgov)	Phase 3	COVID-19	1,800	Ivermectin (Arm A - Ivermectin 400)	hnkcnqsatn(qtvoisfqwt) = qzwcfvqthx lprarxyheh (nkgvorgusl, bvohffdvqe - medtkmjigs) View more	-	11 Apr 2023
				Placebo (Arm A - Placebo)	hnkcnqsatn(qtvoisfqwt) = myhemrsgdv lprarxyheh (nkgvorgusl, hrjduujehe - fcqtstnxwf) View more
NCT04885530 (ACTIV-6, Pubmed \| JAMA)	Phase 3	COVID-19	1,206	Ivermectin	(uogkfezqrs) = vdpgezixfv kphtpvmfwn (csdrcrcxle )	Negative	20 Feb 2023
				Placebo	(uogkfezqrs) = hvkpkynhzb kphtpvmfwn (csdrcrcxle )
NCT04510194 (COVID-OUT, Pubmed)	Phase 3	COVID-19	-	Metformin	wilkfecwcx(cuzxyszbrm) = dfvyfrgjuy akeereozhb (buushbhvyy )	Positive	23 Dec 2022
				Ivermectin	wilkfecwcx(cuzxyszbrm) = clhbdjsauk akeereozhb (buushbhvyy )