MedPath

Tradipitant

Generic Name
Tradipitant
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C28H16ClF6N5O
CAS Number
622370-35-8
Unique Ingredient Identifier
NY0COC51FI
Background

Tradipitant has been used in trials studying the treatment and prevention of Eczema, Pruritus, Gastroparesis, Chronic Pruritus, and Atopic Dermatitis, among others.

Associated Conditions
-
Associated Therapies
-
benzinga.com
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Vanda Pharma (NASDAQ:VNDA) Stock Quotes, Forecast and News

FDA rejected Vanda Pharmaceuticals' tradipitant for gastroparesis, requesting more studies. Vanda disputes, claiming efficacy, and intends to seek approval.
pharmaphorum.com
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Vanda slams FDA rejection of gastroparesis drug

The FDA rejected Vanda Pharma's tradipitant for gastroparesis, citing insufficient evidence and requesting further studies. Vanda criticized the decision, claiming the drug meets efficacy standards. Gastroparesis affects ~6M in the US. Vanda remains committed to tradipitant's approval, also testing it for motion sickness. Vanda's stock dropped post-announcement, amidst financial pressures and recent takeover attempts.
finance.yahoo.com
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3 Under-$10 Drug Stocks Wall Street Analysts Recommend Buying

2024 mixed for biotech; sector down 14% due to Q3 results, guidance cuts, pipeline setbacks, and vaccine skeptic nominee. Despite challenges, biotech remains attractive for innovation and M&A activity. Recommended stocks: Allogene Therapeutics (ALLO), Rezolute (RZLT), Vanda Pharmaceuticals (VNDA), all under $10 with strong Zacks Rank and ABR.

DC Circuit Affirms FDA's Fast-Track Denial of Vanda Stomach Drug

A federal appeals court affirmed the FDA's decision to deny Vanda Pharmaceuticals Inc.'s gastroparesis drug tradipitant fast-track approval, ruling the FDA reasonably rejected the expedited approval request based on available evidence.
finance.yahoo.com
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Gastroparesis Drugs Market size to increase by USD 1.42 Billion between 2023 to 2028

The global gastroparesis drugs market is projected to grow by USD 1.42 billion from 2024 to 2028, with a CAGR of 3.69%. Key segments include drug class, disease type, and geography. Prokinetic drugs like metoclopramide and domperidone are significant for managing symptoms. New drugs under development aim to improve treatment outcomes.

Gastroparesis for the Nongastroenterologist (Part II)

Gastroparesis diagnosis requires symptoms, exclusion of mechanical obstruction, and evidence of delayed gastric emptying. Gold-standard tests include gastric emptying scintigraphy and the stable isotope gastric-emptying breath test. Management strategies include optimizing nutrition, prokinetic medications, antiemetics, neuromodulators, and nonpharmacologic therapies like gastric electrical stimulation and acupuncture. Surgical options include pyloroplasty and G-POEM for refractory cases.
qz.com
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Vanda Pharmaceuticals Inc (VNDA) Quarterly 10-Q Report

Vanda Pharmaceuticals' Q3 2024 10-Q filing shows total revenues up to $47.7M, driven by PONVORY® and Fanapt® sales. Fanapt® sales rose 12% to $23.9M, HETLIOZ® up 2% to $17.9M, and PONVORY® contributed $5.9M. Despite increased R&D and SG&A expenses, the company reported a net loss of $5.3M. Cash and equivalents totaled $376.3M. Vanda continues to focus on product development and commercialization.
morningstar.com
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Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results

Vanda Pharmaceuticals reports Q3 2024 revenue of $47.7 million, up 23% YoY. Financial guidance for 2024 is revised upwards. Fanapt® launch in bipolar I disorder sees new patient starts increase by over 90% YoY. Fanapt® long-acting injectable program to start in Q4 2024. Milsaperidone NDA for schizophrenia and bipolar I disorder expected in early 2025. PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024. PONVORY® IND applications for psoriasis and ulcerative colitis expected in Q4 2024. Tradipitant NDA for motion sickness to be submitted in Q4 2024.
prnewswire.com
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Gastroparesis Drugs Market to Grow by USD 1.42 Billion from 2024-2028, Driven by Rising ...

Global gastroparesis drugs market to grow by USD 1.42 billion from 2024-2028, driven by rising diabetes prevalence and emerging market opportunities, despite stringent regulatory challenges. Key players include Abbott Laboratories, AbbVie Inc., and others.
medcitynews.com
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J&J Backs Down From 340B Rebates, But Maintains They're 'Legally Permissible' Per Statute

Johnson & Johnson proposed changes to the 340B drug discount program, but backed down after HRSA deemed them inconsistent with the statute. The 340B program, established in 1992, aims to help underserved communities by allowing eligible hospitals and clinics to purchase outpatient prescription medications at discounts. Recent regulatory developments include FDA approvals for Exact Sciences' Cologuard Plus, Partners Fresenius Kabi and Formycon's Otulfi, Eli Lilly's Retevmo, Sanofi and Regeneron's Dupixent, Bristol Myers Squibb's Cobenfy, and others. Additionally, Pfizer withdrew Oxbryta from the market due to safety concerns.
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