Approximately one in five women will experience depression or anxiety during pregnancy or within the first year after giving birth. Without treatment, mothers with these conditions are at increased risk for birth complications, poor overall health, impaired bonding and nurturing of the infant, and death by suicide.
But a new treatment moving through the Food and Drug Administration’s clinical trial process could be the key to treating, and even curing, depression and anxiety in postpartum people. It is a newly named psychedelic, rubesirocin. It works like psilocin, the psychoactive chemical in psilocybin mushrooms. Unlike existing treatments, it may be able to positively impact the unique hormonal changes, brain changes, and disconnections that can cause these symptoms.
In previous studies of psilocybin, researchers have observed rapid improvement, and in some cases cures, in conditions such as major depression and PTSD with just one dose. A recent FDA phase 2 study of rubesirocin found similar improvements in postpartum depression.
I was a facility investigator at the University of Colorado, one of 35 participating facilities across the United States. The study enrolled 84 postpartum women within a year of giving birth and ended in May 2025.
I’ve spent my career as a board-certified obstetrician-gynecologist thinking about how prenatal experiences shape lifelong health. I also closely tracked the psychedelic data. Given that these drugs may be useful in treating other mental health conditions, I was eager to find evidence-based applications for psychedelic drugs during pregnancy and postpartum.
How depression and anxiety affect mothers and babies
One drug that has been studied and improved our understanding of psychedelic mechanisms of action is MDMA, commonly known as ecstasy, which produces a euphoric feeling.
A peer-reviewed study published by Bessel van der Kolk in 2024 found that MDMA may lead to an increased ability of individuals to identify, describe, and feel their emotions. Other improvements resulting from MDMA-assisted therapy include greater compassion for oneself and a broader desire and ability to connect with others.
Connection, especially the earliest connections between mothers and infants, plays the most important role in providing the foundation for humans to grow and thrive. Postpartum depression is often defined by disconnection and decreased bonding.
Children born to mothers with untreated depression or anxiety are at higher risk of falling behind in early development. They may also have behavioral problems, such as hyperactivity or ADHD, and tend to withdraw from social activities. They tend to present with physical complaints such as body aches during early childhood.
Children of mothers who suffered from depression or anxiety during pregnancy are also at risk of developing similar symptoms as teenagers. They have nearly twice the risk of these disorders compared to teens whose mothers did not have untreated depression or anxiety. This pattern means that depression and anxiety can become a multigenerational cycle. However, with proper treatment and support, this cycle can be broken.
Researchers found elevated levels of the hormone oxytocin in the blood of depression study participants who were given MDMA, LSD, and mescaline, all hallucinogens. Increased oxytocin increased feelings of trust, empathy, and connection.
Oxytocin is a hormone produced in a part of the brain called the hypothalamus and released into the bloodstream by the pituitary gland. It plays an important role in childbirth and infant feeding. It also helps wire and shape the human social brain.
Oxytocin is important for mother-infant bonding. Conversely, stressors during early childhood, such as mothers suffering from mental illness, reduce oxytocin levels in children. This can contribute to negative effects on mental and physical health later in life.
In depression studies in men, psilocybin did not have as large an effect on oxytocin production as other psychedelic drugs. However, there is reason to believe that oxytocin may play a greater role in postpartum patients, as oxytocin levels are higher during birth and lactation than at other stages of life.
FDA research on psilocybin-like drugs
In February 2026, the FDA granted breakthrough therapy status to rubesirocin. This status is used to accelerate the development of promising new drugs for serious or life-threatening conditions. The drug earned this status because our study found that treated patients’ depression scores decreased significantly and rapidly.
In a Phase 2 trial, 77% of postpartum women who received a psychedelic dose of 30mg of rubesirocin experienced significant improvement in postpartum depression. Overall, 71% had no symptoms of postpartum depression seven days after the psychedelic session.
The purpose of FDA Phase 2 studies is to determine the effectiveness of an experimental drug for a particular disease or condition. In this case, the study is evaluating the effects of rubesirocin on postpartum depression scores and symptoms. More than half of the group given a small dose of the drug, a placebo, experienced improvement in symptoms, but most still had some symptoms after seven days.
These are much higher response and remission rates than trials of existing drugs used to treat postpartum depression. Existing treatments include selective serotonin reuptake inhibitors, known as SSRIs, and a drug called zuranolone. The latter is the only drug specifically approved by the FDA for postpartum depression.
Access to psychedelic treatments
In 2023, the Colorado General Assembly passed the Natural Medicine Health Act. This provides a legal route for people to ingest natural psychedelics such as psilocybin mushrooms in treatment settings. The first natural medicine healing center opened in early 2026. Some places advertise treatments for everything from postpartum depression to birth trauma.
Oregon has a similar state-regulated program. Many other states have different paths toward legalizing psychedelic-assisted therapy and decriminalizing psilocybin-assisted therapy. Nationally, a federal executive order was recently issued to accelerate treatment of serious mental illnesses. The order included references to the use of psychedelic therapy.
I’m looking forward to it
By the end of 2026, a Phase 3 trial of rubesirocin in postpartum depression is expected to begin. Phase 3 trials are conducted to confirm the effectiveness of a new drug and further evaluate its overall risks and benefits. Each stage is an important regulatory step before a drug is approved and available in clinical practice.
Phase 3 will recruit 200 participants with postpartum depression across participating sites. Although I am optimistic about the potential of this study, I believe its value can only be established through rigorous blinded clinical trials, objective data analysis, and conclusions and acceptance fully supported by evidence.
Phase 3 also includes participants who are still breastfeeding. Studies of rubesirocin during lactation in healthy volunteers demonstrated that very low levels are passed from the mother into breast milk. Therefore, this drug is considered safe for breastfeeding.
Rubesilocin may become a game-changing treatment for postpartum depression in the next few years. On a much larger scale, psychedelic medicine has the potential to replace systemic cycles of depression, anxiety, trauma, and isolation with connection and compassion, increasing our collective happiness and well-being. These drugs can literally rewire our approach to trauma, addiction, and each other.
This article is republished from The Conversation under a Creative Commons license. Read the original article.
