LSD inches closer to FDA approval

lsd fda approval

Lysergic acid diethylamide, also known as LSD or acid, has captured attention since Albert Hofmann took that fateful bike ride. For generations, the compound remained highly illegal, classified as a Schedule I controlled substance by the United Nations. While the scheduling remains, pharmaceutical company MindMed is investigating the potential medical applications of the chemical with MM120.

MM120 is lysergide D-tartrate, a synthesized version of LSD developed by MindMed. After banner results in Phase 2, MindMed is celebrating a positive meeting going into a potential Phase 3 clinical trial for Generalized Anxiety Disorder (GAD).

RELATED: This Ivy League school is going all in on psychedelic research

“We are pleased to have reached alignment on our Phase 3 development strategy for MM120 in GAD,” Rob Barrow, CEO of MindMed, said in a press release. “We are on schedule to initiate our Phase 3 clinical program for MM120 oral dissolving tablet (ODT) in GAD in the second half of this year and look forward to sharing additional details on the design of our pivotal program in the coming months.”

LSD for anxiety

GAD impacts roughly three percent of the U.S. population, with women twice as likely to receive a diagnosis. Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for GAD, and benzodiazepines are often prescribed for immediate symptom relief. Success rates on SSRIs for GAD range around 42 to 77 percent. Some patients choose greener options like cannabis, though the results can be mixed. Both options are continually consumed for the best results.

The concept of psychedelic compounds to treat anxiety symptoms and disorders isn’t new, but MM120 is the first LSD application to move through the US FDA clinical trial process. Phase 2 results were published in March with fanfare, as a single 100 microgram dose led to 48 percent remission from GAD after 12 weeks. What’s more, 65 percent of participants in the multi-center, randomized, double-blind, parallel-group, dose-finding study experienced symptom relief after three months.

Positive results lead to Phase 3

The drug didn’t stir up many issues within the cohort aside from a few minor occurrences that were expected side effects. Overall, results are filed under-promising, and the FDA seems to agree.

“On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial,” said MindMed CEO Daniel R. Karlin, MD.

RELATED: Case study reveals long COVID case seemingly cured by psychedelics

Following the Phase 2B results, the FDA designated MM120 a “Breakthrough Therapy,” signifying that it may demonstrate substantial improvement for a serious or life-threatening condition. The designation also expedites the lengthy FDA clinical trial approvals and processes.

The latest announcement marks a stride to Phase 3, where MM120 will be compared to the current standard treatment. Following the End-of-Phase2 meeting, MindMed is confident Phase 3 will begin before 2025, and Karlin looks forward to possible relief for GAD patients.

“Few treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program,” Karlin concluded.

Cara Wietstock is senior content producer of and has been working in the cannabis space since 2011. She has covered the cannabis business beat for Ganjapreneur and The Spokesman Review. You can find her living in Bellingham, Washington with her husband, son, and a small zoo of pets.