INNOVATE's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by INNOVATE (VATE).
Over the past two years, INNOVATE has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Lumitrace. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Lumitrace FDA Regulatory Events
Lumitrace is a drug developed by INNOVATE for the following indication: for the assessment of kidney function in patients with normal or impaired renal function.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lumitrace
- Announced Date:
- October 21, 2025
- Indication:
- for the assessment of kidney function in patients with normal or impaired renal function.
Announcement
INNOVATE Corp. announced that it has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). Lumitrace will be sold as an integral component of the Transdermal GFR System in China.
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INNOVATE FDA Events - Frequently Asked Questions
As of now, INNOVATE (VATE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, INNOVATE (VATE) has reported FDA regulatory activity for Lumitrace.
The most recent FDA-related event for INNOVATE occurred on October 21, 2025, involving Lumitrace. The update was categorized as "Approved," with the company reporting: "INNOVATE Corp. announced that it has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). Lumitrace will be sold as an integral component of the Transdermal GFR System in China."
Currently, INNOVATE has one therapy (Lumitrace) targeting the following condition: for the assessment of kidney function in patients with normal or impaired renal function..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NYSE:VATE last updated on 10/21/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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