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1. 5,5'-dimethyl-2,2'-bipyridyl
2. Dmbp Cpd
1. 1762-34-1
2. 5,5'-dimethyl-2,2'-bipyridine
3. 5,5'-dimethyl-2,2'-dipyridyl
4. 6,6'-bi-3-picoline
5. 5,5'-dimethyl-2,2'-bipyridyl
6. Xeglyze
7. Ha-44
8. 2,2'-bipyridine, 5,5'-dimethyl-
9. 5-methyl-2-(5-methylpyridin-2-yl)pyridine
10. Brn 0123183
11. 6,6'-di-3-picolyl
12. 6,6'-di-3-picoline
13. Ha44
14. 6uo390amfb
15. Chembl2205807
16. 5,5'-dimethyl-2,2'-bipyridinyl
17. Mfcd01740554
18. Abametapir [usan:inn]
19. Unii-6uo390amfb
20. Xeglyze(abametapir)
21. Xeglyze (tn)
22. Abametapir [mi]
23. Abametapir [inn]
24. Abametapir (usan/inn)
25. Abametapir [usan]
26. Abametapir [who-dd]
27. Schembl351152
28. Yssj3184
29. 2,2 -bis-(5-methylpyridyl)
30. Abametapir [orange Book]
31. Dtxsid00170095
32. Chebi:192617
33. Zinc403335
34. Bdbm50401351
35. Lt0042
36. S5752
37. 5,5''-dimethyl-2,2''-bipyridine
38. Akos005257775
39. Cs-w004546
40. Db11932
41. Hy-w004546
42. Sb17220
43. 5,5'-dimethyl-2,2'-dipyridyl, 98%
44. Ds-15219
45. Sy052805
46. Ft-0689891
47. D10687
48. D70523
49. W-108621
50. Q27265547
51. 5,5 Inverted Exclamation Mark -dimethyl-2,2 Inverted Exclamation Mark -bipyridyl
| Molecular Weight | 184.24 g/mol |
|---|---|
| Molecular Formula | C12H12N2 |
| XLogP3 | 2.2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 1 |
| Exact Mass | 184.100048391 g/mol |
| Monoisotopic Mass | 184.100048391 g/mol |
| Topological Polar Surface Area | 25.8 Ų |
| Heavy Atom Count | 14 |
| Formal Charge | 0 |
| Complexity | 161 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Abametapir is indicated, in the context of an overall lice management program, for the topical treatment of head lice infestation in patients 6 months of age and older.
Abametavir has been shown to inhibit all stages of embryo development in both head and body lice by interfering with enzymes critical to this process. It is relatively unique amongst lice treatments in that it requires only a single application, whereas many current therapies require two applications, due to its exceptional potency and unique mechanism. Its predominant metabolite, abametapir carboxyl, has a prolonged residence time in the body, with an estimated half-life of 71 40 hours or longer in adults - as this metabolite has been shown to inhibit cytochrome P450 enzymes _in vitro_, the use of substrates of CYP3A4, CYP2B6, or CYP1A2 should be avoided for two weeks following the administration of abametapir. Abametapir lotion is formulated with [benzyl alcohol], which has been associated with significant toxicity following unintentional systemic exposure, particularly in neonates and low birth weight infants. Benzyl alcohol-containing formulations should not be administered to patients <6 months of age, and should be administered to pediatric patients cautiously and under direct supervision of an adult to mitigate the risk of unintentional oral ingestion.
P - Antiparasitic products, insecticides and repellents
P03 - Ectoparasiticides, incl. scabicides, insecticides and repellents
P03A - Ectoparasiticides, incl. scabicides
P03AX - Other ectoparasiticides, incl. scabicides
P03AX07 - Abametapir
Absorption
In a pharmacokinetic trial with both adult and pediatric patients, the Cmax and AUC0-8h in the adult group were 41 ng/mL and 121 ng.h/mL and the Cmax and AUC0-8h in the pediatric group were 73 ng/mL and 264 ng.h/mL. In general, systemic exposure to abametapir appears to decrease with increasing age. The median Tmax of abemetapir is 0.57 - 1.54 hours. Following topical administration, benzyl alcohol was found in detectable quantities in the serum of 7 out of 39 pediatric patients. The Cmax of benzyl alcohol in these subjects ranged from 0.52 to 3.57 g/mL. The predominant circulating metabolite of abemetapir (abemtapir carboxylate) is eliminated slowly from the circulation and is therefore found at higher serum concentrations than its parent drug - based on data collected for 72 hours post-administration, the ratios of serum Cmax and AUC0-72h between abametapir and abametapir carboxylate were approximately 30 and 250, respectively.
Route of Elimination
The clearance and excretion of abametapir has not been examined in patients.
Volume of Distribution
Data regarding the volume of distribution of abametapir are not available.
Clearance
The clearance and excretion of abametapir has not been examined in patients.
The biotransformation of abametapir is extensive and primarily mediated by CYP1A2. It is metabolized first to abametapir hydroxyl and then further to abametapir carboxyl - the latter is cleared slowly from the plasma, resulting in higher systemic concentrations than that of the parent drug. _In vitro_ studies suggest that abametapir carboxyl may act as an inhibitor of CYP3A4, CYP2B6, and CYP1A2, particularly at the relatively high and prolonged concentrations observed following topical administration of abametapir.
The elimination half-lives of abametapir and its metabolites have not been well-characterized, but the estimated half-life of abametapir carboxyl is 71 40 hours (or longer) in adults.
There are several metalloproteinases (enzymes requiring metal co-factors to function) involved in the process of louse egg hatching and survival. _In vitro_ studies have demonstrated that metal-chelating agents can inhibit the activity of these proteins, and may therefore be valuable pediculicidal agents. Abametapir is a metalloproteinase inhibitor that targets louse metalloproteinases which are critical to their development and hatching.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34305
Submission : 2019-11-15
Status : Inactive
Type : II

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34305
Submission : 2019-11-15
Status : Inactive
Type : II

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Details:
XEGLYZE (Abametapir), contains benzyl alcohol. Systemic exposure to benzyl alcohol has been associated with serious and fatal adverse reactions including “gasping syndrome” in neonates and low birth weight infants.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Xeglyze
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2020
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy's Laboratories Received Approval of XEGLYZE™ (abametapir) Lotion, 0.74%, in the U.S.
Details : XEGLYZE (Abametapir), contains benzyl alcohol. Systemic exposure to benzyl alcohol has been associated with serious and fatal adverse reactions including “gasping syndrome” in neonates and low birth weight infants.
Product Name : Xeglyze
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 27, 2020
Details:
Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Lice Infestations.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2014
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 27, 2014
Details:
Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lice Infestations.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Accelovance | Syneos Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2014
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Accelovance | Syneos Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 13, 2014
Details:
Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pediculus.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2014
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion
Details : Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pediculus.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 13, 2014
Details:
Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pediculus.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: TKL Research, Inc. | Accelovance
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2014
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : TKL Research, Inc. | Accelovance
Deal Size : Inapplicable
Deal Type : Inapplicable
Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion
Details : Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pediculus.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 13, 2014
Details:
Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lice Infestations.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Accelovance | Syneos Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2014
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Accelovance | Syneos Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 12, 2014
Details:
Ha44 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Lice Infestations.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 12, 2013
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ha44 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 12, 2013
Details:
Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Lice Infestations.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 26, 2012
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Details : Abametapir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 26, 2012
Details:
Ha44 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Lice Infestations.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 18, 2011
Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ha44 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 18, 2011
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Details:
Through the acquisition of Abametapir, targeting MMPs, the deal aims to advance treatments for head lice infestation.
Lead Product(s): Abametapir,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xeglyze
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Hatchtech Pty Ltd
Deal Size: $1.8 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 05, 2026

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Lead Product(s) : Abametapir,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Hatchtech Pty Ltd
Deal Size : $1.8 million
Deal Type : Acquisition
Pelthos Therapeutics Acquires Xeglyze® Topical Treatment for Head Lice
Details : Through the acquisition of Abametapir, targeting MMPs, the deal aims to advance treatments for head lice infestation.
Product Name : Xeglyze
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 05, 2026

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : XEGLYZE
Dosage Form : LOTION;TOPICAL
Dosage Strength : 0.74%
Packaging :
Approval Date : 2020-07-24
Application Number : 206966
Regulatory Info : DISCN
Registration Country : USA

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RLD : Yes
TE Code :
Brand Name : XEGLYZE
Dosage Form : LOTION;TOPICAL
Dosage Strength : 0.74%
Approval Date : 2020-07-24
Application Number : 206966
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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PharmaCompass offers a list of Abametapir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Abametapir manufacturer or Abametapir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Abametapir manufacturer or Abametapir supplier.
PharmaCompass also assists you with knowing the Abametapir API Price utilized in the formulation of products. Abametapir API Price is not always fixed or binding as the Abametapir Price is obtained through a variety of data sources. The Abametapir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DB11932 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DB11932, including repackagers and relabelers. The FDA regulates DB11932 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DB11932 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of DB11932 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DB11932 supplier is an individual or a company that provides DB11932 active pharmaceutical ingredient (API) or DB11932 finished formulations upon request. The DB11932 suppliers may include DB11932 API manufacturers, exporters, distributors and traders.
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A DB11932 DMF (Drug Master File) is a document detailing the whole manufacturing process of DB11932 active pharmaceutical ingredient (API) in detail. Different forms of DB11932 DMFs exist exist since differing nations have different regulations, such as DB11932 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DB11932 DMF submitted to regulatory agencies in the US is known as a USDMF. DB11932 USDMF includes data on DB11932's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DB11932 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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DB11932 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of DB11932 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right DB11932 GMP manufacturer or DB11932 GMP API supplier for your needs.
A DB11932 CoA (Certificate of Analysis) is a formal document that attests to DB11932's compliance with DB11932 specifications and serves as a tool for batch-level quality control.
DB11932 CoA mostly includes findings from lab analyses of a specific batch. For each DB11932 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
DB11932 may be tested according to a variety of international standards, such as European Pharmacopoeia (DB11932 EP), DB11932 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DB11932 USP).