Investigational Research and Clinical Trial Access
How investigational psychedelic and related drugs reach people legally in the United States: clinical trials, FDA expanded access and Right to Try, as read from FDA and the trial registry.
Content last updated . This page has not been medically reviewed.
This page explains the legal routes by which an investigational drug can reach a person. It is not advice to join any study, and it contains no instructions for obtaining any substance. Speak with your own doctor about your situation. In a mental health crisis in the United States, call or text 988; for an emergency, call 911.
What "investigational" means
An investigational drug has not been approved by the regulator for the use being studied. The FDA states that investigational products have not been approved or cleared and that it has not found them safe and effective for their specific use. [1] A product can be investigational for one condition and approved for another, so the condition always matters. For approved status, see medical approval.Route 1: clinical trials
Clinical trials are the main route for investigational psychedelic and related drugs. A trial follows a written protocol that sets out who may take part, what is given, how participants are monitored and what is measured. Trials of drugs like these are run by universities, hospitals and companies.ClinicalTrials.gov is a public registry run by the U.S. National Library of Medicine. Its data interface reported 325 registered studies matching the term "psilocybin" and 105 of those marked as recruiting, as of the data timestamp 2026-10-22. [2] Those counts include studies of many designs, in many countries, of different drugs and of conditions that differ, and a match on the term does not mean the substance is the focus of the study. A registry entry describes a plan, not a result. Our guides on finding and understanding registered clinical trials and how to read a psychedelic clinical trial explain how to read a record.
Clinical Trial Access. A trial has eligibility rules, and some people will not qualify. Joining a trial involves informed consent; see informed consent in psychedelic research and care. Trial participation is not a way to buy or keep a product, and we do not list trials or sites here.
Route 2: FDA expanded access
The FDA describes expanded access, sometimes called "compassionate use," as a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product outside a clinical trial when no comparable or satisfactory alternative therapy options are available. [1] It may be appropriate only when conditions such as the following all apply: there is no comparable or satisfactory alternative, trial enrollment is not possible, the potential benefit justifies the risks, and access will not interfere with trials that could support approval. [1] The FDA adds that the product may or may not be effective and may cause unexpected serious side effects. [1]Expanded access is a physician-led request process with the FDA and, usually, the drug's maker. We found no psychedelic-specific expanded access program on the pages we read, so we make no claim that any exists for a particular drug.
Route 3: Right to Try
The federal Right to Try Act is another pathway. The FDA says an eligible patient has a life-threatening disease or condition, has exhausted approved treatment options and is unable to take part in a clinical trial of the drug, and has given written informed consent. [3] An eligible investigational drug must, among other things, have completed a Phase 1 trial and be the subject of an active investigational new drug application with ongoing development. [3] The FDA states that its role is limited to receiving and posting certain information, and that companies decide whether to make products available. [3]What these routes are not
- They are not a retreat, clinic or private-service pathway. For those, see evaluating clinic claims and evaluating retreat claims.
- They are not a state-licensed service; see supervised-service frameworks.
- They are not a route for people who simply want to try a substance. Each requires a qualifying condition and, for the last two, a physician.
Evidence labels
Insufficient evidence applies to many investigational uses. A study being registered or recruiting says nothing about whether the treatment works.Other countries: we did not read non-US regulator pages this session, so we do not describe their trial or access rules.
Frequently asked questions
Is a recruiting trial proof that a treatment works?
No. A registry record describes what a study plans to do. [2] Whether it works is shown by completed, reported results.
What is expanded access?
The FDA calls it a potential pathway to an investigational product outside a trial for people with serious or immediately life-threatening conditions and no comparable alternative. [1]
Who can use Right to Try?
Per the FDA, patients with life-threatening conditions who have exhausted approved options, cannot join a trial of the drug, and have given written informed consent. [3]
Does the FDA decide whether a company gives a drug under Right to Try?
The FDA says companies are responsible for determining whether to make products available to patients who qualify. [3]
Where can I check current trial details?
The ClinicalTrials.gov registry shows each study's design, locations and status. [2] Talk to your own doctor before acting on a listing.