FDA Events for 180 Life Sciences (ATNF)
This section highlights FDA-related milestones and regulatory updates for drugs developed by 180 Life Sciences (ATNF).
Over the past two years, 180 Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Epidiolex. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Epidiolex (cannabidiol) - FDA Regulatory Timeline and Events
Epidiolex (cannabidiol) is a drug developed by 180 Life Sciences for the following indication: Epilepsy with Myoclonic-Atonic Seizures (EMAS).
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:
- Epidiolex (cannabidiol)
- Announced Date:
- July 30, 2024
- Indication:
- Epilepsy with Myoclonic-Atonic Seizures (EMAS)
Announcement
180 Life Sciences Corp. announced topline results from a clinical pharmacology study (the "Study"), that evaluated the uptake of cannabidiol (CBD) in a solid formulation which can be delivered as a pill orally.
AI Summary
180 Life Sciences Corp. announced topline results from a clinical pharmacology study that looked at how cannabidiol (CBD) is absorbed when delivered in a solid pill form. The study compared two different solid formulations of CBD with Epidiolex, an FDA-approved liquid CBD medication used for epilepsy. In the trial, 12 adult volunteers received all three formulations in a crossover, randomized format. Results showed that one of the solid formulations was absorbed faster and reached higher peak levels compared to Epidiolex, while both pill forms were well tolerated. These findings suggest that delivering CBD as a pill may offer more predictable and efficient dosing. The study aims to address the challenge of CBD’s low and variable uptake when given in liquid form, potentially opening the door for future clinical trials to explore CBD’s benefits for conditions such as pain and inflammation.
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180 Life Sciences FDA Events - Frequently Asked Questions
As of now, 180 Life Sciences (ATNF) has not received any FDA approvals for its therapy in the last two years.
In the past two years, 180 Life Sciences (ATNF) has reported FDA regulatory activity for Epidiolex (cannabidiol).
The most recent FDA-related event for 180 Life Sciences occurred on July 30, 2024, involving Epidiolex (cannabidiol). The update was categorized as "Top-line results," with the company reporting: "180 Life Sciences Corp. announced topline results from a clinical pharmacology study (the "Study"), that evaluated the uptake of cannabidiol (CBD) in a solid formulation which can be delivered as a pill orally."
Currently, 180 Life Sciences has one therapy (Epidiolex (cannabidiol)) targeting the following condition: Epilepsy with Myoclonic-Atonic Seizures (EMAS).
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:ATNF) was last updated on 7/11/2025 by MarketBeat.com Staff
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