Synopsis
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1. (2r,4s,4as)-11-fluoro-2,4-dimethyl-8-((4s)-4-methyl-2-oxo-1,3-oxazolidin-3-yl)-1,2,4,4a-tetrahydro-2'h,6h-spiro((1,2)-oxazolo(4,5-g)(1,4)oxazino(4,3-a)quinoline-5,5'-pyrimidine)-2',4',6'(1'h,3'h)-trione
2. Azd-0914
3. Azd0914
4. Etx-0914
5. Etx0914
1. 1620458-09-4
2. Azd0914
3. Azd-0914
4. Zoliflodacin [usan]
5. Etx0914
6. Etx-0914
7. Fwl2263r77
8. (2r,4s,4as)-11-fluoro-2,4-dimethyl-8-((4s)-4-methyl-2-oxo-1,3-oxazolidin-3-yl)-1,2,4,4a-tetrahydro-2'h,6h-spiro((1,2)-oxazolo(4,5-g)(1,4)oxazino(4,3-a)quinoline-5,5'-pyrimidine)-2',4',6'(1'h,3'h)-trione
9. Unii-fwl2263r77
10. Zoliflodacin(azd0914)
11. Zoliflodacin (usan/inn)
12. Zoliflodacin [inn]
13. Zoliflodacin [who-dd]
14. Azd 0914 - Bio-x
15. Chembl3544978
16. Schembl15879500
17. Gtpl10875
18. Azd0914etx0914
19. Ext0914
20. Bdbm139376
21. Dtxsid101028418
22. Azd 0914
23. Ex-a2620
24. Ext-0914
25. Etx0914; Azd0914; Zoliflodacin
26. Db12817
27. Ac-35757
28. Ba164192
29. Hy-17647
30. Cs-0016917
31. D11726
32. Us8889671, 5
33. Q27278240
34. (2r,4s,4as)-11-fluoro-2,4-dimethyl-8-((s)-4-methyl-2-oxooxazolidin-3-yl)-1,2,4,4a-tetrahydro-2'h,6h-spiro[isoxazolo[4,5-g][1,4]oxazino[4,3-a]quinoline-5,5'-pyrimidine]-2',4',6'(1'h,3'h)-trione
35. (2r,4s,4as)-11-fluoro-2,4-dimethyl-8-((s)-4-methyl-2-oxooxazolidin-3-yl)-2,4,4a,6-tetrahydro-1h,1'h-spiro[isoxazolo[4,5-g][1,4]oxazino[4,3-a]quinoline-5,5'-pyrimidine]-2',4',6'(3'h)-trione
36. (4'r,6's,7's)-17'-fluoro-4',6'-dimethyl-13'-[(4s)-4-methyl-2-oxo-1,3-oxazolidin-3-yl]spiro[1,3-diazinane-5,8'-5,15-dioxa-2,14-diazatetracyclo[8.7.0.02,7.012,16]heptadeca-1(17),10,12(16),13-tetraene]-2,4,6-trione
37. (7s,11r,13s)-3-((4s)-2-oxo-4-methyltetrahydrooxazole-3-yl)-9-fluoro-11,13-dimethyl-8,7-(ethanoxymethano)-7,8,1',2',3',4'-hexahydrospiro[isoxazolo[4,5-g]quinoline-6(5h),5'(6'h)-pyrimidine]-2',4',6'-trione
38. Spiro(isoxazolo(4,5-g)(1,4)oxazino(4,3-a)quinoline-5(6h),5'(2'h)-pyrimidine)-2',4',6'(1'h,3'h)-trione, 11-fluoro-1,2,4,4a-tetrahydro-2,4-dimethyl-8-((4s)-4-methyl-2-oxo-3-oxazolidinyl)-, (2r,4s,4as)-
| Molecular Weight | 487.4 g/mol |
|---|---|
| Molecular Formula | C22H22FN5O7 |
| XLogP3 | 1.3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 1 |
| Exact Mass | 487.15032622 g/mol |
| Monoisotopic Mass | 487.15032622 g/mol |
| Topological Polar Surface Area | 143 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 962 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Treatment of gonococcal infection
Topoisomerase II Inhibitors
Compounds that inhibit the activity of DNA TOPOISOMERASE II. Included in this category are a variety of ANTINEOPLASTIC AGENTS which target the eukaryotic form of topoisomerase II and ANTIBACTERIAL AGENTS which target the prokaryotic form of topoisomerase II. (See all compounds classified as Topoisomerase II Inhibitors.)
Drugs in Development
Details:
Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Lead Product(s): Zoliflodacin,Azithromycin,Ceftriaxone
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: The Global Antibiotic Research and Development Partnership
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 17, 2020
Lead Product(s) : Zoliflodacin,Azithromycin,Ceftriaxone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership
Deal Size : Undisclosed
Deal Type : Agreement
GARDP, Dr. Reddy’s and Aurigene Pharmaceutical Services Limited Sign MOU for Antibiotic Access T...
Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Undisclosed
December 17, 2020
Details:
Zoliflodacin, an antibiotic targeting DNA gyrase and Topoisomerase IV, shows promise in treating uncomplicated urogenital gonorrhea.
Lead Product(s): Zoliflodacin,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzolvence
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: The Global Antibiotic Research and Development Partnership
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 12, 2025
Lead Product(s) : Zoliflodacin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Approves NUZOLVENCE® for Uncomplicated Urogenital Gonorrhea in Adults
Details : Zoliflodacin, an antibiotic targeting DNA gyrase and Topoisomerase IV, shows promise in treating uncomplicated urogenital gonorrhea.
Product Name : Nuzolvence
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 12, 2025
Details:
ETX-0914 (zoliflodacin) has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.
Lead Product(s): Zoliflodacin,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: ETX-0914
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Global Antibiotic Research & Development
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 10, 2025
Lead Product(s) : Zoliflodacin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Global Antibiotic Research & Development
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts NDA for Innoviva’s Zoliflodacin Oral Antibiotic for Gonorrhea
Details : ETX-0914 (zoliflodacin) has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.
Product Name : ETX-0914
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 10, 2025
Details:
Zoliflodacin, an antibiotic, is currently undergoing evaluation in late-stage clinical trials with patients for treating gonorrhea, in combination with ceftriaxone/azithromycin.
Lead Product(s): Zoliflodacin,Azithromycin,Ceftriaxone
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 24, 2024
Lead Product(s) : Zoliflodacin,Azithromycin,Ceftriaxone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Innoviva’s Zoliflodacin Phase 3 Data in Uncomplicated Gonorrhea Announced at ESCMID 2024
Details : Zoliflodacin, an antibiotic, is currently undergoing evaluation in late-stage clinical trials with patients for treating gonorrhea, in combination with ceftriaxone/azithromycin.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 24, 2024
Details:
Zoliflodacin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Zoliflodacin,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Parexel | KCAS Bio
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 02, 2022
Lead Product(s) : Zoliflodacin,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Parexel | KCAS Bio
Deal Size : Inapplicable
Deal Type : Inapplicable
Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
Details : Zoliflodacin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 02, 2022
Details:
Toripalimab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Exocrine Pancreatic Insufficiency.
Lead Product(s): Toripalimab,Zoliflodacin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2021
Lead Product(s) : Toripalimab,Zoliflodacin
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Oral CDX-7108 in Healthy Adults and EPI Subjects
Details : Toripalimab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Exocrine Pancreatic Insufficiency.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
October 18, 2021
Details:
Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Lead Product(s): Zoliflodacin,Azithromycin,Ceftriaxone
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: The Global Antibiotic Research and Development Partnership
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 17, 2020
Lead Product(s) : Zoliflodacin,Azithromycin,Ceftriaxone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership
Deal Size : Undisclosed
Deal Type : Agreement
GARDP, Dr. Reddy’s and Aurigene Pharmaceutical Services Limited Sign MOU for Antibiotic Access T...
Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Undisclosed
December 17, 2020
Details:
Toripalimab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Toripalimab,Zoliflodacin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 12, 2020
Lead Product(s) : Toripalimab,Zoliflodacin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Surufatinib DDI With a PPI and a CYP3A Inducer
Details : Toripalimab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
August 12, 2020
Details:
Zoliflodacin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Gonorrhea.
Lead Product(s): Zoliflodacin,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Quotient Sciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2018
Lead Product(s) : Zoliflodacin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Quotient Sciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
Details : Zoliflodacin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Gonorrhea.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 24, 2018
Details:
AZD0914 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Zoliflodacin,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 24, 2014
Lead Product(s) : Zoliflodacin,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AZD0914 Phase 1 ADME Study in Healthy Volunteers
Details : AZD0914 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 24, 2014
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD :
TE Code :
Brand Name : NUZOLVENCE
Dosage Form : SUSPENSION; ORAL
Dosage Strength : 3G
Approval Date :
Application Number : 219491
RX/OTC/DISCN :
RLD :
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
ABOUT THIS PAGE
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PharmaCompass offers a list of Zoliflodacin 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 Zoliflodacin manufacturer or Zoliflodacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zoliflodacin manufacturer or Zoliflodacin supplier.
PharmaCompass also assists you with knowing the Zoliflodacin API Price utilized in the formulation of products. Zoliflodacin API Price is not always fixed or binding as the Zoliflodacin Price is obtained through a variety of data sources. The Zoliflodacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zoliflodacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zoliflodacin, including repackagers and relabelers. The FDA regulates Zoliflodacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zoliflodacin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Zoliflodacin supplier is an individual or a company that provides Zoliflodacin active pharmaceutical ingredient (API) or Zoliflodacin finished formulations upon request. The Zoliflodacin suppliers may include Zoliflodacin API manufacturers, exporters, distributors and traders.
Zoliflodacin 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 Zoliflodacin 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 Zoliflodacin GMP manufacturer or Zoliflodacin GMP API supplier for your needs.
A Zoliflodacin CoA (Certificate of Analysis) is a formal document that attests to Zoliflodacin's compliance with Zoliflodacin specifications and serves as a tool for batch-level quality control.
Zoliflodacin CoA mostly includes findings from lab analyses of a specific batch. For each Zoliflodacin 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.
Zoliflodacin may be tested according to a variety of international standards, such as European Pharmacopoeia (Zoliflodacin EP), Zoliflodacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zoliflodacin USP).
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
