Likelihood of Approval and Phase Transition Success Rate Model – Vonoprazan Fumarate in Nonerosive Reflux Disease (NERD)

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Vonoprazan Fumarate in Nonerosive Reflux Disease (NERD)

Published: November 17, 2023 Report Code: GDHCDR120LOA-MP-L5

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How likely is it that a drug will get approved? Will the drug transition to the next phase of its clinical pathway? This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.


Vonoprazan Fumarate in Nonerosive Reflux Disease (NERD) Drug Details:

Vonoprazan fumarate (Takecab, Inzelm, Vocinti, Denziza) is a novel anti-secretory drug, acts as gastrointestinal protective agent. It is formulated as film-coated tablets and tablets for the oral route of administration. It is indicated in gastric ulcer, duodenal ulcer, reflux esophagitis, erosive esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration, prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug (NSAID) administration, as an adjunct to Helicobacter pylori eradication in the gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early-stage gastric cancer, or Helicobacter pylori gastritis.Vonoprazan is under development for the treatment ofHelicobacter pylori infections, gastro-esophageal reflux disease in patients who have a partial response following treatment with a proton pump inhibitor and erosive esophagitis, gastric cancer, eosinophilic esophagitis (EoE) and nonerosive reflux disease (NERD). The drug candidate is a potassium-competitive acid blocker (P-CAB). It is formulated as a capsule and tablet for oral route of administration. It was also under development for nonerosive reflux disease (NERD) and duodenal ulcer adjunct to Helicobacter pylori eradication.

Report Coverage

The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.

The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.

Quick View – Vonoprazan Fumarate LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Vonoprazan Fumarate
Administration Pathway
· Oral
Therapeutic Areas
· Gastrointestinal| Infectious Disease| Oncology
Key Manufacturers
· Phathom Pharmaceuticals Inc
Drug Development Status
· Phathom Pharmaceuticals Inc

Reasons to Buy

  • Predict the specific likelihood of approval and phase transition success rates of a drug using a combination of machine learning and proprietary models

  • Get information on LOA and PTSR for competitors’ drugs to plan your clinical development, commercialization and marketing strategies

  • Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR

  • Use PTSR and LOA information and event-driven changes for your investment decisions.

Frequently asked questions

    The probability of a drug ultimately receiving market authorization

    The probability of a drug’s advancement to the next stage of clinical development

    GlobalData’s  Drug-Specific Likelihood of Approval (LoA) calculates the  Phase Transition Success Rate (PTSR) and  Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of  Machine Learning (ML) and a  GlobalData proprietary algorithm to process data points from the  Drugs, Clinical Trials, Regulatory Milestones, Company, and  Financial databases.

     

    Inclusion

    Data Scope:

    • Drugs which have been approved in the past 10 years
    • Drugs which have failed during clinical development in the past 18 years
    • Drugs which are currently in development

    Drug Phase Scope:

    • Phase I, Phase II, Phase III, and Pre-Registration development stage

    Drug Geography Scope:

    • Drugs must meet one of the following criteria to be included in the model:
    • The developer has specified the US as an intended market for approval.
    • The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”

    Drug Type Scope:

    • Innovator drugs and biosimilars

    Entity Type Scope:

    Only drugs in development by companies are included in the model.

    Exclusion

    • Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
    • Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
    • Generic drugs
    • Innovative drugs in Preclinical or Discovery Stage.
    • Pipeline drugs sponsored by a Government or Institution.
    • Drugs with a specific Drug Geography not the United States.

     

lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Vonoprazan Fumarate in Nonerosive Reflux Disease (NERD)
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