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Home » 2020 APPROVALS » Abametapir アバメタピル , абаметапир , أباميتابير , 阿巴甲吡 ,

Abametapir アバメタピル , абаметапир , أباميتابير , 阿巴甲吡 ,

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Abametapir skeletal.svg

Abametapir

アバアバメタピル , абаметапир , أباميتابير 阿巴甲吡 ,

5,5′-dimethyl-2,2′-bipyridine, 6,6′-Bi-3-picoline

  • BRN 0123183
  • HA 44
  • HA-44
  • HA44
Formula
C12H12N2
CAS
1762-34-1
Mol weight
184.2371

Xeglyze, FD APPROVED 24/7/2020

Pediculicide, Metalloproteinase inhibitor
  Disease
Head lice infestation
  • Originator Hatchtech
  • DeveloperDr Reddys Laboratories; Hatchtech
  • ClassAntiparasitics; Heterocyclic compounds; Pyridines; Small molecules
  • Mechanism of ActionChelating agents; Metalloprotease inhibitors
  • Registered Pediculosis
  • 27 Jul 2020Registered for Pediculosis (In adolescents, In children, In infants, In adults) in USA (Topical)
  • 18 Jun 2020FDA assigns PDUFA action date of 12/08/2020 for Abametapir for Pediculosis (Dr Reddy’s Laboratories website, June 2020)
  • 31 Mar 2019Abametapir is still in preregistration phase for Pediculosis in USA

Abametapir is a novel pediculicidal metalloproteinase inhibitor used to treat infestations of head lice.4 The life cycle of head lice (Pediculus capitis) is approximately 30 days, seven to twelve of which are spent as eggs laid on hair shafts near the scalp.2 Topical pediculicides generally lack adequate ovicidal activity,2 including standard-of-care treatments such as permethrin, and many require a second administration 7-10 days following the first to kill newly hatched lice that resisted the initial treatment. The necessity for follow-up treatment may lead to challenges with patient adherence, and resistance to agents like permethrin and pyrethrins/piperonyl butoxide may be significant in some areas.3

Investigations into novel ovicidal treatments revealed that several metalloproteinase enzymes were critical to the egg hatching and survival of head lice, and these enzymes were therefore identified as a potential therapeutic target.1 Abemetapir is an inhibitor of these metalloproteinase enzymes, and the first topical pediculicide to take advantage of this novel target. The improved ovicidal activity (90-100% in vitro) of abemetapir allows for a single administration, in contrast to many other topical treatments, and its novel and relatively non-specific mechanism may help to curb the development of resistance to this agent.1

Abametapir was first approved for use in the United States under the brand name Xeglyze on July 27, 2020.6

Abametapir, sold under the brand name Xeglyze, is a medication used for the treatment of head lice infestation in people six months of age and older.[1][2]

The most common side effects include skin redness, rash, skin burning sensation, skin inflammation, vomiting, eye irritation, skin itching, and hair color changes.[2]

Abametapir is a metalloproteinase inhibitor.[1] Abametapir was approved for medical use in the United States in July 2020.[1][3]

Medical uses

Abametapir is indicated for the topical treatment of head lice infestation in people six months of age and older.[1][2]

History

The U.S. Food and Drug Administration (FDA) approved abametapir based on evidence from two identical clinical trials of 699 participants with head lice.[2] The trials were conducted at fourteen sites in the United States.[2]

The benefit and side effects of abametapir were evaluated in two clinical trials that enrolled participants with head lice who were at least six months old.[2]

About half of all enrolled participants was randomly assigned to abametapir and the other half to placebo.[2] Abametapir lotion or placebo lotion were applied once as a ten-minute treatment to infested hair.[2] The benefit of abametapir in comparison to placebo was assessed after 1, 7 and 14 days by comparing the counts of participants in each group who were free of live lice.[2]

SYN

Ronald Harding, Lewis David Schulz, Vernon Morrison Bowles, “Pediculicidal composition.” WIPO Patent WO2015107384A2, published July, 2015.

References

  1. Jump up to:a b c d e “Xeglyze (abametapir) lotion, for topical use” (PDF)U.S. Food and Drug Administration (FDA). Dr. Reddy’s Laboratories. Inc. Retrieved 25 July 2020.
  2. Jump up to:a b c d e f g h i “Drug Trial Snapshot: Xeglyze”U.S. Food and Drug Administration (FDA). 24 July 2020. Retrieved 6 August 2020.  This article incorporates text from this source, which is in the public domain.
  3. ^ “Abametapir: FDA-Approved Drugs”U.S. Food and Drug Administration (FDA). Retrieved 25 July 2020.

Further reading

External links

  • “Abametapir”Drug Information Portal. U.S. National Library of Medicine.
Abametapir
Abametapir skeletal.svg
Clinical data
Trade names Xeglyze
Other names Ha44
AHFS/Drugs.com Professional Drug Facts
License data
Pregnancy
category
  • US: N (Not classified yet)
Routes of
administration
Topical
Drug class PediculicideMetalloproteinase inhibitor
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
CompTox Dashboard (EPA)
ECHA InfoCard 100.157.434 Edit this at Wikidata
Chemical and physical data
Formula C12H12N2
Molar mass 184.242 g·mol−1
3D model (JSmol)

///////Abametapir, 2020 APPROVALS, FDA 2020, Xeglyze, アバメタピル , абаметапир , أباميتابير 阿巴甲吡 , BRN 0123183, HA 44, head lice

CC1=CC=C(N=C1)C1=CC=C(C)C=N1


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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