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Also known as: 1000296-70-7, 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, Sulopenem etzadroxil (usan), Sulopenem etzadroxil [usan], Pf-03709270, 492m3i304t
Molecular Formula
C19H27NO7S3
Molecular Weight
477.6  g/mol
InChI Key
NBPVNGWRLGHULH-CSOWVJSESA-N
FDA UNII
492M3I304T

Sulopenem Etzadroxil
Sulopenem Etzadroxil is an orally available ester prodrug form of sulopenem, a thiopenem with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria. After oral administration of sulopenem etzadroxil, the ester bond is cleaved, releasing active sulopenem. Sulopenem is not active against Pseudomonas aeruginosa. In addition, this agent is fairly stable against hydrolysis by various beta-lactamases.
1 2D Structure

Sulopenem Etzadroxil

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C19H27NO7S3/c1-4-11(5-2)17(23)26-9-27-18(24)14-19(28-12-6-7-30(25)8-12)29-16-13(10(3)21)15(22)20(14)16/h10-13,16,21H,4-9H2,1-3H3/t10-,12+,13+,16-,30-/m1/s1
2.1.3 InChI Key
NBPVNGWRLGHULH-CSOWVJSESA-N
2.1.4 Canonical SMILES
CCC(CC)C(=O)OCOC(=O)C1=C(SC2N1C(=O)C2C(C)O)SC3CCS(=O)C3
2.1.5 Isomeric SMILES
CCC(CC)C(=O)OCOC(=O)C1=C(S[C@H]2N1C(=O)[C@@H]2[C@@H](C)O)S[C@H]3CC[S@@](=O)C3
2.2 Other Identifiers
2.2.1 UNII
492M3I304T
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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

2.4 Create Date
2008-01-14
3 Chemical and Physical Properties
Molecular Weight 477.6 g/mol
Molecular Formula C19H27NO7S3
XLogP32.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count10
Rotatable Bond Count11
Exact Mass477.09496572 g/mol
Monoisotopic Mass477.09496572 g/mol
Topological Polar Surface Area180 Ų
Heavy Atom Count30
Formal Charge0
Complexity767
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

Drugs in Development

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Details:

Sulopenem Etzadroxil is a Antibiotic drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Bacterial Infections.


Lead Product(s): Sulopenem Etzadroxil,Probenecid

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 30, 2025

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Details : Sulopenem Etzadroxil is a Antibiotic drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Bacterial Infections.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

July 30, 2025

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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: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 25, 2024

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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

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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

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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

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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: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 19, 2022

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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

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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 July 11, 2022

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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

July 11, 2022

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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: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 25, 2022

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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

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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: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 28, 2021

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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

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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: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 27, 2021

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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

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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 February 09, 2021

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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

February 09, 2021

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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: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 25, 2021

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The Battery Show
Not Confirmed
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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

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FDF Dossiers

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PROBENECID; SULOPENEM ETZADROXIL

Brand Name : ORLYNVAH

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG;500MG

Packaging :

Approval Date : 2024-10-25

Application Number : 213972

Regulatory Info : DISCN

Registration Country : USA

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FDA Orange Book

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PROBENECID; SULOPENEM ETZADROXIL

Brand Name : ORLYNVAH

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG;500MG

Approval Date : 2024-10-25

Application Number : 213972

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 

Impressions: 11368

https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

#PharmaFlow by PHARMACOMPASS
30 Jan 2025

STOCK RECAP #PipelineProspector

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Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking
In October, several pharma companies posted their third quarter (Q3) results. Drugmakers like Pfizer, BMS, Roche, Novartis, Sanofi, Merck and Incyte reported higher-than-expected Q3 earnings, beating analyst expectations. Despite these healthy results, pharma indices continued on their downward journey that had begun in September. The Nasdaq Biotechnology Index (NBI) dropped 2.6 percent from 4,771.85 to 4,650.07. The SPDR S&P Biotech ETF (XBI) fell 1.6 percent from 98.61 to 97.03, and the S&P Biotechnology Select Industry Index (SPSIBI) decreased 1.9 percent from 7,707.4 to 7,561.29.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Lundbeck buys Longboard, AbbVie picks up Aliada, Merck acquires Modifi in US$ 1 bn+ deals In mergers and acquisitions, Denmark’s Lundbeck agreed to buy California-based Longboard Pharmaceuticals for US$ 2.6 billion. The acquisition centers around bexicaserin, a promising phase 3 candidate for rare epilepsies including Dravet syndrome and Lennox-Gastaut syndrome, with Lundbeck projecting potential peak sales of US$ 1.5 billion to US$ 2 billion for this asset.  AbbVie acquired Boston-based Aliada Therapeutics for US$ 1.4 billion after reportedly outbidding at least three other drugmakers. The acquisition brings innovative blood-brain barrier technology to AbbVie’s portfolio, along with ALIA-1758, a phase 1 compound showing potential as a best-in-class therapy for Alzheimer’s disease. AbbVie also partnered with EvolveImmune Therapeutics in a potential US$ 1.4 billion deal (plus US$ 65 million upfront) to develop next-generation cancer biotherapeutics. The collaboration will leverage EvolveImmune’s innovative T-cell engager platform to create multispecific biologics targeting various oncology indications. Merck bolstered its oncology pipeline through the acquisition of Modifi Biosciences in a deal valued up to US$ 1.3 billion. The acquisition targets novel DNA modification therapeutics for challenging brain tumors, particularly glioblastomas. Merck  also entered into a potential US$ 1.9 billion deal with Mestag Therapeutics to explore fibroblast therapies for inflammatory diseases, leveraging Mestag’s innovative platform.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Pfizer, Novartis, Biogen sign molecular glue degrader deals; Astra in US$ 2 bn pact with CSPC There were at least three deals signed in October in the molecular glue degrader technology space. These degraders represent a novel therapeutic approach by facilitating the degradation of disease-causing proteins that are otherwise difficult to target with conventional drugs. First, Pfizer partnered Triana Biomedicines in a deal potentially exceeding US$ 1.5 billion, focusing on cancer applications. Second, Novartis committed US$ 150 million upfront to Monte Rosa Therapeutics in a deal worth up to US$ 2.25 billion. And Biogen tied up with Neomorph, pledging up to US$ 1.45 billion for neurological and immunological applications. Among other deals, AstraZeneca entered into a US$ 2 billion licensing agreement with CSPC Pharmaceutical Group for a novel lipid-lowering therapy, while Recordati acquired global rights to Sanofi’s Enjaymo for US$ 825 million upfront, with additional milestone payments of up to US$ 250 million. The Recordati-Sanofi deal focuses on cold agglutinin disease (CAD), a rare autoimmune disorder, and includes rights to sutimlimab, the first and only targeted therapy for CAD patients. Roche demonstrated its commitment to gene therapy advancement by expanding its collaboration with Dyno Therapeutics, committing over US$ 1 billion for adeno-associated virus (AAV) vector development, with an upfront payment of US$ 50 million. This expanded partnership builds on their initial 2020 collaboration and aims to accelerate the development of innovative gene therapies for neurological diseases.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) AbbVie wins FDA nod for subcutaneous Parkinson’s drug; Roche med okayed for breast cancer October marked significant advances in the treatment of several major diseases. FDA approved AbbVie’s Vyalev for advanced Parkinson’s disease. This innovative therapy, utilizing foscarbidopa and foslevodopa prodrugs, delivers round-the-clock symptom control through subcutaneous infusion. The treatment represents a major advancement in managing motor fluctuations in late-stage patients, with market analysts projecting peak sales exceeding US$ 2 billion. In the oncology space, a historic milestone was reached with FDA’s approval of Vyloy, the world’s first therapy targeting CLDN18.2 proteins in gastric cancer. Developed by Astellas, the drug was approved for use in combination with chemotherapy for treating advanced gastric or gastroesophageal junction adenocarcinoma in adults with HER2-negative, CLDN18.2-positive tumors. This approval validates Astellas’ strategic US$ 1.4 billion acquisition of Ganymed Pharmaceuticals in 2016. Roche strengthened its position in breast cancer treatment with the approval of Itovebi, an oral PI3K inhibitor for first-line treatment of advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation. This approval positions Itovebi as a strong competitor to existing treatments like Novartis' Piqray and AstraZeneca's Truqap, with Roche projecting annual peak sales of US$ 2.3 billion. Novartis expanded the reach of its leukemia treatment Scemblix through an accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This expansion significantly increases the eligible patient population by approximately four times, building on its existing approval as a third-line treatment. Pfizer expanded its presence in the respiratory syncytial virus (RSV) market as FDA broadened the approval of Abrysvo to include at risk adults aged 18 to 50 years, making it the first and only RSV vaccine authorized for this population. In hematology, Pfizer secured approval for Hympavzi marking its second hemophilia approval in six months. This approval follows the earlier authorization of Pfizer’s one-time gene therapy Beqvez for hemophilia B in April. Iterum Therapeutics received FDA approval for its new oral antibiotic, Orlynvah, designed to treat uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative oral antibacterial treatment options. This marks the first US approval for an oral penem antibiotic.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Gilead withdraws Trodelvy, J&J discontinues late-stage study of its bladder cancer candidate In a notable development for bladder cancer treatment, Gilead Sciences announced the withdrawal of Trodelvy from the US market after the targeted therapy, which received accelerated FDA approval in 2021 for metastatic urothelial cancer, failed to demonstrate survival benefits in a crucial confirmatory study.  Johnson & Johnson decided to discontinue the late-stage study of TAR-200, their investigational bladder cancer therapy, after interim analysis showed no superior benefits compared to standard chemo-radiation therapy. In neurology, Marinus Pharmaceuticals faced disappointment when their phase 3 trial of oral ganaxolone (Ztalmy) failed to meet its primary endpoint in reducing seizures associated with tuberous sclerosis complex (a genetic disorder). Marinus’ stock fell nearly 100 percent in October.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Our view The last quarter was a good one for several drugmakers. Pfizer saw a surge in sales of its Covid drug Paxlovid to US$ 2.7 billion, encouraging it to up its guidance for Covid-related sales from US$ 8.5 billion to US$ 10.5 billion. For BMS, blockbusters like blood thinner Eliquis and cancer treatment Revlimid continued to bring in revenue. Merck’s growth was driven by the world’s top-selling drug, Keytruda, which saw revenue jump 17 percent compared to Q3 2023, beating analysts’ estimates. In a nutshell, the robust Q3 earnings of major pharma companies signals strong industry fundamentals, the volatility in pharma indices notwithstanding.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)

Impressions: 3633

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-oct-2024-lundbeck-acquires-longboard-for-us-2-6-bn-molecular-glue-degrader-tech-witnesses-dealmaking

#PharmaFlow by PHARMACOMPASS
07 Nov 2024

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https://www.fiercepharma.com/pharma/breaking-down-dual-track-strategy-behind-iterums-launch-first-new-uncomplicated-uti-drug

FIERCE PHARMA
20 Aug 2025

Patents & EXCLUSIVITIES

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US Exclusivities

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PROBENECID; SULOPENEM ETZADROXIL

Exclusivity Code : NCE

Exclusivity Expiration Date : 2029-10-25

Application Number : 213972

Product Number : 1

Exclusivity Details :

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PROBENECID; SULOPENEM ETZADROXIL

Exclusivity Code : GAIN

Exclusivity Expiration Date : 2034-10-25

Application Number : 213972

Product Number : 1

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Looking for 1000296-70-7 / Sulopenem Etzadroxil API manufacturers, exporters & distributors?

Sulopenem Etzadroxil manufacturers, exporters & distributors 1

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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.

API | Excipient name

Sulopenem Etzadroxil

Synonyms

1000296-70-7, 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, Sulopenem etzadroxil (usan), Sulopenem etzadroxil [usan], Pf-03709270, 492m3i304t

Cas Number

1000296-70-7

Unique Ingredient Identifier (UNII)

492M3I304T

About Sulopenem Etzadroxil

Sulopenem Etzadroxil is an orally available ester prodrug form of sulopenem, a thiopenem with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria. After oral administration of sulopenem etzadroxil, the ester bond is cleaved, releasing active sulopenem. Sulopenem is not active against Pseudomonas aeruginosa. In addition, this agent is fairly stable against hydrolysis by various beta-lactamases.

Sulopenem Etzadroxil Manufacturers

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.

Sulopenem Etzadroxil Suppliers

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 GMP

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.

Sulopenem Etzadroxil CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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