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1. 1000296-70-7
2. 2-ethylbutanoyloxymethyl (5r,6s)-6-[(1r)-1-hydroxyethyl]-7-oxo-3-[(1r,3s)-1-oxothiolan-3-yl]sulfanyl-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
3. Sulopenem Etzadroxil (usan)
4. Sulopenem Etzadroxil [usan]
5. Pf-03709270
6. 492m3i304t
7. Sulopenem-etzadroxil
8. Pf 03709270
9. Schembl3412832
10. Dtxsid80635293
11. 4-thia-1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic Acid, 6-((1r)-1-hydroxyethyl)-7-oxo-3-(((1r,3s)-tetrahydro-1-oxido-3-thienyl)thio)-, (2-ethyl-1-oxobutoxy)methyl Ester, (5r,6s)-
12. Ex-a3685
13. Pf 03709270 (ulopenem Etzadroxil)
14. Ac-33246
15. Hy-109754
16. Cs-0033925
17. D09672
18. Q27259210
19. (2-ethyl-1-oxobutoxy)methyl (5r,6s)-6-[(1r)-1-hydroxyethyl]-7-oxo-3-[[(1r,3s)-tetrahydro-1-oxido-3-thienyl]thio]-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
20. (2-ethyl-1-oxobutoxy)methyl (5r,6s)-6-[(1r)-1-hydroxyethyl]-7-oxo-3-[[(1r,3s)-tetrahydro-1-oxido-3-thienyl]thio]-4thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
21. Methylene 2-ethylbutanoate (5r,6s)-6-((1r)-1-hydroxyethyl)-7-oxo-3-(((1r,3s)-1-oxotetrahydro-1h-1.lamba.(sup 4)-thiophen-3-yl)sulfanyl)-4-thia-1-azabicyclo(3.2.0)hept-2-ene-2-carboxylate
| Molecular Weight | 477.6 g/mol |
|---|---|
| Molecular Formula | C19H27NO7S3 |
| XLogP3 | 2.1 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 11 |
| Exact Mass | 477.09496572 g/mol |
| Monoisotopic Mass | 477.09496572 g/mol |
| Topological Polar Surface Area | 180 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 767 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Drugs in Development
Details:
Orlynvah (sulopenem etzadroxil & probenecid) is a combination product candidate, which is indicated for the treatment of uncomplicated urinary tract infections.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 25, 2024
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Approves Iterum's Treatment for Urinary Infection
Details : Orlynvah (sulopenem etzadroxil & probenecid) is a combination product candidate, which is indicated for the treatment of uncomplicated urinary tract infections.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 25, 2024
Details:
Oral Sulopenem (sulopenem etzadroxil/probenecid) is a cell wall inhibitor which is being evaluated in phase 3 clinical trials for the treatment of uncomplicated urinary tract infections & cystitis.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 30, 2024
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Announces Positive Results From Phase 3 REASSURE Trial Of Oral Sulopenem In UTIs
Details : Oral Sulopenem (sulopenem etzadroxil/probenecid) is a cell wall inhibitor which is being evaluated in phase 3 clinical trials for the treatment of uncomplicated urinary tract infections & cystitis.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 30, 2024
Details:
Food and Drug Administration under the special protocol assessment process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: US Food & Drug Administration
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 07, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : US Food & Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
Details : Food and Drug Administration under the special protocol assessment process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated ur...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Undisclosed
November 07, 2022
Details:
Sulopenem Etzadroxil is a novel penem anti-infective compound, in Phase 3 clinical development. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
Details : Sulopenem Etzadroxil is a novel penem anti-infective compound, in Phase 3 clinical development. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibioti...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 19, 2022
Details:
Sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 25, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibio...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 25, 2022
Details:
Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 28, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem
Details : Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 28, 2021
Details:
The Company intends to use the net proceeds for the ongoing review of its NDA for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen, for pre-commercialization and potential launch activities for oral sulopenem.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: H.C. Wainwright & Co
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 02, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $35.0 million
Deal Type : Public Offering
Details : The Company intends to use the net proceeds for the ongoing review of its NDA for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen, for pre-commercialization and potential launch activities for...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Undisclosed
September 02, 2021
Details:
During the meeting, the FDA shared issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 27, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Provides Update on NDA Review
Details : During the meeting, the FDA shared issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susce...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
May 27, 2021
Details:
Sulopenem is a novel penem anti-infective compound. The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 25, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sulopenem is a novel penem anti-infective compound. The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 25, 2021
Details:
The Company intends to use the net proceeds from this offering to support its planned NDA submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem.
Lead Product(s): Sulopenem Etzadroxil
Therapeutic Area: Infections and Infectious Diseases Brand Name: Orlynvah
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: H.C. Wainwright & Co
Deal Size: $17.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Lead Product(s) : Sulopenem Etzadroxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $17.5 million
Deal Type : Public Offering
Iterum Therapeutics Announces Pricing of $17.5 Million Upsized Public Offering
Details : The Company intends to use the net proceeds from this offering to support its planned NDA submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical dev...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Undisclosed
October 23, 2020
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sulopenem Etzadroxil 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 Sulopenem Etzadroxil manufacturer or Sulopenem Etzadroxil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulopenem Etzadroxil manufacturer or Sulopenem Etzadroxil supplier.
PharmaCompass also assists you with knowing the Sulopenem Etzadroxil API Price utilized in the formulation of products. Sulopenem Etzadroxil API Price is not always fixed or binding as the Sulopenem Etzadroxil Price is obtained through a variety of data sources. The Sulopenem Etzadroxil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sulopenem Etzadroxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulopenem Etzadroxil, including repackagers and relabelers. The FDA regulates Sulopenem Etzadroxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulopenem Etzadroxil 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 Sulopenem Etzadroxil supplier is an individual or a company that provides Sulopenem Etzadroxil active pharmaceutical ingredient (API) or Sulopenem Etzadroxil finished formulations upon request. The Sulopenem Etzadroxil suppliers may include Sulopenem Etzadroxil API manufacturers, exporters, distributors and traders.
Sulopenem Etzadroxil 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 Sulopenem Etzadroxil 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 Sulopenem Etzadroxil GMP manufacturer or Sulopenem Etzadroxil GMP API supplier for your needs.
A Sulopenem Etzadroxil CoA (Certificate of Analysis) is a formal document that attests to Sulopenem Etzadroxil's compliance with Sulopenem Etzadroxil specifications and serves as a tool for batch-level quality control.
Sulopenem Etzadroxil CoA mostly includes findings from lab analyses of a specific batch. For each Sulopenem Etzadroxil 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.
Sulopenem Etzadroxil may be tested according to a variety of international standards, such as European Pharmacopoeia (Sulopenem Etzadroxil EP), Sulopenem Etzadroxil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sulopenem Etzadroxil USP).
