677 Patents and One FDA Rejection: Mapping the Psychedelic Drug Pipeline

Our own count of who's filing patents on psilocybin, MDMA, LSD, ketamine, ibogaine, and 5-MeO-DMT — what they're claiming to treat, where they're based, and the one company that's already been told no by the FDA.

We built a patent tracker off a live pull from TREA, an IP intelligence platform, covering seven compounds: psilocybin, MDMA, LSD, ketamine, ibogaine, DMT, and 5-MeO-DMT. This is the overview — how many patents exist, who filed them, what they're claimed to treat, and where the FDA has already said no.

The Numbers

	Count
Granted patents	211
Pending applications	466
Companies holding at least one	88

Full company-by-company breakdown, tickers, and expiration estimates are on the Altitude Intelligence patent tracker. We identified 211 granted patents and 466 pending applications via TREA, an IP intelligence platform, while UC Berkeley's Center for the Science of Psychedelics — working with Psychedelic Alpha and the IP firm Calyx Law — tracks 1,309 patents across the same compound set, including international PCT filings alongside US ones. The two datasets use different inclusion criteria and different scope, so they're not directly comparable line for line — but together they make one thing clear: however you count it, this is a crowded, actively-filed field.

Who's Filing, and Where

By granted-patent count, the current leaders in our data are Compass Pathfinder Limited (COMPASS Pathways, Nasdaq: CMPS — 13 grants, mostly psilocybin), Enveric Biosciences (Nasdaq: ENVB — 12, psilocybin), and Turtle Bear Holdings, a privately held entity (10, psilocybin and 5-MeO-DMT). Berkeley's broader tracker names CaaMTech (private), GH Research (Nasdaq: GHRS), Gilgamesh (private), AtaiBeckley (Nasdaq: ATAI), and Compass Pathways as 2025's most active filers — company-registered filers on a public database, not commercial recommendations.

Most of what we pulled from TREA is US-format patent activity. Berkeley's tracker mixes in PCT and international filings too, which is a real chunk of its larger total — but no source we found publishes a clean US-versus-international split, so we're not going to invent one. What's fair to say: the filing activity isn't confined to the US, but the clearest picture of who's filing is still concentrated among a handful of repeat players — the same names showing up across psilocybin, 5-MeO-DMT, and ketamine claims.

What They're Claiming to Treat

Patent claims map fairly cleanly onto each compound's lead clinical indication: psilocybin and ketamine patents cluster around depression, MDMA around PTSD, ibogaine around substance use disorder, LSD around anxiety, and 5-MeO-DMT around treatment-resistant depression specifically. That's not a coincidence — it tracks the indications furthest along in trials, which we cover on our Trials tracker.

The One That's Already Been Rejected

Patents are a bet on a future approval. One major psychedelic drug program has already collected on that bet and lost, at least once: Lykos Therapeutics — the MAPS-affiliated company that developed MDMA-assisted therapy for PTSD — got a Complete Response Letter from the FDA on August 9, 2024. The agency's stated concerns: unreported adverse events at multiple trial sites, insufficient evidence on how durable the effect actually was, and selection-bias risk, since a large share of participants had prior recreational MDMA experience, which raised questions about how blinded the trial really was.

The fallout was severe — roughly 75% of staff laid off, the CEO and most of the board turned over, MAPS founder Rick Doblin resigned from the board. In August 2025 the company renamed itself Resilient Pharmaceuticals under new leadership. As of this month, trade reporting indicates Resilient has quietly resubmitted its MDMA NDA to the FDA — not with a new Phase 3 trial, but leaning on a small VA follow-up dataset, a new cardiac-safety study, and an audit of the original trial records. That resubmission hasn't been confirmed by the company directly as of this writing, so treat it as reported, not announced.

The FDA has since issued formal guidance, in July 2026, on how psychedelic trials should handle blinding, therapist standardization, and long-term follow-up — directly responsive to what sank the original MDMA application. Every other program in this space is now filing against that guidance, whether they say so or not.

One narrower setback: GH Research's (Nasdaq: GHRS) inhaled 5-MeO-DMT program was placed under an FDA clinical hold, then cleared in January 2026. As of this writing, the company has FDA feedback that its manufacturing and device plans are "Phase 3 ready," but hasn't yet started that trial.

What to Watch

Three programs picked up FDA National Priority Vouchers in April 2026 — a fast-track mechanism that compresses review time once an application is filed:

COMPASS Pathways (Nasdaq: CMPS — COMP360, psilocybin, treatment-resistant depression) — targeting a completed rolling NDA submission by Q4 2026.
Usona Institute (donor-funded nonprofit, no ticker — psilocybin, major depressive disorder) — broader indication than COMPASS, Phase 3 results not yet announced.
Otsuka (TSE: 4578) / Transcend Therapeutics (TSND-201, an MDMA analog, PTSD) — Phase 3 underway now, after Otsuka's $1.2 billion acquisition of Transcend earlier this year.

All three vouchers trace back to an April 2026 executive order directing the FDA to expedite review of Breakthrough-designated psychedelic compounds. A public hearing tied to that same push is scheduled for September 2026 — worth watching regardless of where you land on any one drug.

We'll be back with compound-specific deep dives on psilocybin, 5-MeO-DMT, and LSD patent activity over the next two weeks.

This is business and regulatory reporting, not medical advice. No compound discussed here is FDA-approved for the indications listed.