Lifestyle

Inventera Inc. Secures U.S. Active Pharmaceutical Ingredient Approval… Accelerating Commercialization to Target a 2.2 Trillion Market

SONG YOUNG-DOO
2026-10-06 10:02:02
Inventera Inc. CI (Photo courtesy of Inventera Inc.)


[Edaily Reporter SONG YOUNG-DOO ] #Inventera Inc.’s new drug candidate “INV-002,” a contrast agent for magnetic resonance arthrography (MR arthrography), has secured the official U.S. generic name “Ferucadextran.” Following the completion of Phase 3 clinical trials in South Korea, the company plans to apply for marketing authorization in the fourth quarter of this year and will set out to target the global MR arthrography market, which is projected to reach approximately 2.2 trillion won by 2030.

Inventera Inc. announced today that “Ferucadextran,” the ingredient name for INV-002, has been adopted as a USAN (United States Adopted Name), the official U.S. drug ingredient name.

USAN is an ingredient name selected by the USAN Committee—comprising the American Medical Association (AMA), the United States Pharmacopeia (USP), and the American Pharmaceutical Association (APhA)—based on the chemical and pharmacological characteristics of the drug. With this adoption, INV-002 now has an official ingredient name separate from its development code. The adoption of the ingredient name is distinct from marketing authorization by the U.S. Food and Drug Administration (FDA).

INV-002 is an iron-based T1 nano-MRI contrast agent developed based on Inventera Inc.’s proprietary nanopharmaceutical platform. It was specifically developed for MR arthrography, which provides imaging of the interior of joints. Perucadextran is the active ingredient in INV-002.

According to the company, current MR arthrography procedures involve diluting intravenous gadolinium contrast agents and administering them into the joint cavity. In contrast, INV-002 is designed to be administered directly into the joint cavity without a separate dilution process.

Based on the results of a recently completed Phase 3 clinical trial in South Korea, Inventera Inc. plans to apply for marketing authorization from the Ministry of Food and Drug Safety in the fourth quarter of this year. The company is preparing for commercialization with the goal of launching the product in South Korea in 2027, and plans to expand its business into overseas markets, such as the United States, following its domestic launch.

According to a report by market research firm The Insight Partners cited by the company, the global MR arthrography market is projected to grow at an average annual rate of around 8% from approximately 1.65 trillion won this year, surpassing 2.2 trillion won by 2030.

An Inventera Inc. official stated, “Following the successful completion of the Phase 3 clinical trial for INV-002 in Korea and the securing of its official generic name, preparations for marketing authorization and commercialization are proceeding in sequence,” adding, “We will proceed without delay with the marketing authorization application in the fourth quarter of this year and target the global MR arthrography market, starting with commercialization in Korea.”

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