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-089 and INM-901. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
INM-089 - FDA Regulatory Timeline and Events
INM-089 is a drug developed by InMed Pharmaceuticals for the following indication: In The Treatment Of Dry Age-Related Macular Degeneration.
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-089
- Announced Date:
- April 16, 2024
- Indication:
- In The Treatment Of Dry Age-Related Macular Degeneration
Announcement
InMed Pharmaceuticals Inc announced additional preclinical data for INM-089 further demonstrating positive pharmacological effects targeting dry Age-Related Macular Degeneration (“AMD”).
Read Announcement
INM-901 - FDA Regulatory Timeline and 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
Free INM Stock Alerts