Omadacycline tosylate is under clinical development by Paratek Pharmaceuticals and currently in Phase I for Osteomyelitis. According to GlobalData, Phase I drugs for Osteomyelitis have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Omadacycline tosylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Omadacycline tosylate overview
Omadacycline tosylate (Nuzyra) is a derivative of aminomethylcycline acts as an anti-bacterial and antibiotic agent. It is formulated as film coated tablets for oral route of administration and lyophilized powder for solution for intravenous route of administration. Nuzyra is indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI), in adults.
Omadacycline (PTK-0796) is under development for the treatment of cystitis, bacterial infections including, skin and skin structure infections caused by bacteria, complicated lower urinary tract infections (cUTI), acute pyelonephritis, diabetic foot infection, Escherichia coli infections, Bacillus anthracis infections (anthrax) and Yersinia pestis (Plague) infections, non-tuberculous mycobacteria (M. abscessus) and bone and joint infections. It is administered intravenously and orally. It belongs to the class of aminomethylcyclines, it is a modernized tetracycline. The drug is based on TET antibacterial technology platform. It was also under development for Neisseria gonorrhoeae infections, Haemophilus influenza infections, acute sinusitis and complicated skin and skin structure infections (cSSSI).
Paratek Pharmaceuticals overview
Paratek Pharmaceuticals (Paratek), a subsidiary of Novo Holdings AS, is a biopharmaceutical company that develops and commercializes therapies based on tetracycline chemistry. The company focuses on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. Nuzyra (Omadacycline), the company’s lead product candidate is an USFDA-approved broad-spectrum antibiotic for the treatment of adults with community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections caused by susceptible bacteria. Its other product Seysara (sarecycline) is also an USFDA-approved drug for the treatment of inflammatory acne vulgaris in patients aged nine or older. Paratek is headquartered in King of Prussia, Pennsylvania, the US.
For a complete picture of Omadacycline tosylate’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
