BG

Bulgaria

Key Insights

  • 1

    No psychedelic therapy is approved in Bulgaria; patient access is limited to standard psychiatric medicines, with esketamine appearing only in clinical research settings.

  • 2

    Blossom records 8 Bulgarian trials, 0 active, 0 research organisations; psilocybin and esketamine dominate, with placebo as the main comparator.

  • 3

    Bulgaria’s standout marker is not a domestic psychedelic programme but its inclusion in multinational esketamine trial networks spanning Sofia and other cities.

  • 4

    Momentum hinges on multinational sponsors, not local institutions: current activity is imported, and no Bulgarian research organisation is listed in the database.

Medical Only (Private)

Reimbursed Care Access

Bulgaria maintains a restrictive legal regime for classical and novel psychedelics: most compounds (psilocybin, MDMA, DMT, 5‑MeO‑DMT, ibogaine, ayahuasca, mescaline, 2C‑X) are scheduled and have no authorised medical use outside of approved research, while ketamine remains an accepted medicinal anesthetic (and is used off‑label in psychiatry) and esketamine (Spravato®) is authorised in the EU and listed for reimbursement in Bulgaria under the National Health Insurance Fund (NHIF) with specific prescribing and supervision requirements. Clinical research is possible but tightly regulated and access outside trials is largely limited to licensed medical products and settings. Relevant regulatory oversight is exercised by the Ministry of Health and the National Council on Prices and Reimbursement / NHIF for reimbursement decisions; criminal enforcement of possession and trafficking is governed by Bulgarian narcotics control and penal provisions. [https://www.ema.europa.eu/en/medicines/human/EPAR/spravato|European Medicines Agency — Spravato] [https://www.pharmahelp.bg/home/productdetails?pcode=2741|PharmaHelp — Spravato (Bulgaria listing)] [https://lex.bg/bg/laws/ldoc/2135758694|Bulgarian law portal (drug control framework)].

Full guide →

Quick Indicators

Active Trials
0
Total Trials
8
Organizations
0
Events
0
Reimbursement Guide→All Countries→Clinical Trials→Research Papers→

Clinical Trials

Active and completed clinical trials investigating psychedelic-assisted therapies in Bulgaria.

TerminatedPhase II

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

Started
CompletedPhase IV

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

Started
CompletedPhase III

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/​Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)

Started
CompletedPhase II

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Started
CompletedPhase III

A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE I)

Started
CompletedPhase III

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)

Started