InMed Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by InMed Pharmaceuticals (INM).
Over the past two years, InMed Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INM-901. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
INM-901 FDA Regulatory Events
INM-901 is a drug developed by InMed Pharmaceuticals for the following indication: To Reduced Alzheimer's-Related Inflammation.
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:
- INM-901
- Announced Date:
- June 24, 2025
- Indication:
- To Reduced Alzheimer's-Related Inflammation
Announcement
InMed Pharmaceuticals Inc. announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential as a therapeutic candidate in Alzheimer's disease.
AI Summary
InMed Pharmaceuticals Inc. announced promising preclinical data on its drug candidate, INM-901. The study showed that INM-901 significantly reduced inflammation in ex vivo models of neuroinflammation using animal brain tissue treated with lipopolysaccharide (LPS). Key inflammatory markers, such as IL-6, IL-1β, IL-2, and KC/Gro, were reduced, along with a significant decrease in the inflammasome marker NLRP3.
This reduction occurred independent of amyloid beta or tau pathology, which are typically associated with Alzheimer’s disease. The findings support the potential of INM-901 as a therapeutic candidate for Alzheimer’s, as it directly targets neuroinflammation—a known factor in neurodegenerative diseases. These results add to the growing evidence that INM-901 could play a significant role in reducing brain inflammation linked to cognitive decline.
Read Announcement- Drug:
- INM-901
- Announced Date:
- January 21, 2025
- Indication:
- To Reduced Alzheimer's-Related Inflammation
Announcement
InMed Pharmaceuticals Inc announces positive results from a long-term in vivo preclinical Alzheimer's Disease ('AD') study.
AI Summary
InMed Pharmaceuticals Inc. announced positive results from its long-term in vivo preclinical study for its ocular drug candidate, INM-089, aimed at treating age-related macular degeneration (AMD). The study showed that INM-089, a cannabinoid analog, provides significant neuroprotection by preserving photoreceptor function and improving retinal pigment epithelium integrity. The results highlighted improvements in retinal function and structure, including increased thickness in the outer nuclear layer and decreased buildup of extracellular deposits—a hallmark of dry AMD. These encouraging findings suggest that INM-089 could help slow disease progression in patients suffering from dry AMD, which affects the majority of those with the condition. InMed is now advancing its next steps, including scaling up manufacturing processes and refining drug formulations, with the goal of moving toward clinical trials and, ultimately, providing a new treatment option for this prevalent and currently limited-to-treat eye disease.
Read Announcement
InMed Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, InMed Pharmaceuticals (INM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, InMed Pharmaceuticals (INM) has reported FDA regulatory activity for INM-901.
The most recent FDA-related event for InMed Pharmaceuticals occurred on June 24, 2025, involving INM-901. The update was categorized as "New preclinical data," with the company reporting: "InMed Pharmaceuticals Inc. announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential as a therapeutic candidate in Alzheimer's disease."
Currently, InMed Pharmaceuticals has one therapy (INM-901) targeting the following condition: To Reduced Alzheimer's-Related Inflammation.
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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 NASDAQ:INM last updated on 6/24/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
