1 domain / 2 areas / 1 specialization
Reconnect Labs
Reconnect Labs AG is a Swiss clinical-stage company and University of Zurich spin-off developing precision psychopharmacology therapeutics, including sublingual DMT/harmine, sublingual 5-MeO-DMT, and sublingual dexmedetomidine. Founded in 2021 by Dr. Davor Kosanic (CEO) and co-founders from the Psychiatric University Clinic Zurich and ETH Zurich, building on ~30 years of in-human psychedelic research. The company raised CHF 22M+ (CHF 12M equity across Seed 2021 and Series A 2023–2025; CHF 10M in competitive grants from investors including Esperante Ventures, Lionheart Ventures, Negev Capital, and Noetic Fund) before emerging from stealth in August 2025. Their microcarrier-based transmucosal delivery platform (exclusively licensed) dramatically reduces inter-subject PK variability for DMT/harmine vs. oral ayahuasca and eliminates vomiting. RE03 (sublingual dexmedetomidine for insomnia in PTSD) is the most advanced programme with Swissmedic approval and FDA accelerated pathway confirmed.
Development Programmes
3RE03 (Sublingual Dexmedetomidine)
Sublingual dexmedetomidine for insomnia in PTSD. Dexmedetomidine is an alpha-2 adrenergic agonist already FDA-approved as IV sedative (Precedex) and sublingual for agitation (Igalmi/BXCL501). RE03 repurposes for PTSD-associated insomnia. Phase 2a actively recruiting (NCT06685965). FDA accelerated development pathway confirmed. Publication in Anesthesiology (March 2025).
Programme Tracker
PTSD
Phase 2a actively RECRUITING (NCT06685965). Sublingual dexmedetomidine for insomnia in PTSD patients. FDA has confirmed accelerated development pathway. Publication in Anesthesiology (March 2025) supports mechanism. BIO 2026 presentation scheduled.
Milestones
regulatory-milestone
CompletedActual: Jan 1, 2025
FDA confirms accelerated development pathway for RE03 (sublingual dexmedetomidine) for insomnia in PTSD.
Why it matters: FDA accelerated pathway reduces development timeline and cost. Leverages existing dexmedetomidine safety database (IV Precedex approved 1999, sublingual Igalmi approved 2022). PTSD-associated insomnia has no FDA-approved treatment — unmet medical need designation likely.
data-readout
CompletedActual: Mar 1, 2025
Publication in Anesthesiology (March 2025) supporting sublingual dexmedetomidine mechanism for insomnia. Provides preclinical/translational evidence for RE03 approach in PTSD-associated sleep disturbance.
Why it matters: Peer-reviewed publication in a top-tier journal (Anesthesiology) validates the mechanistic rationale. Dexmedetomidine produces a unique sleep-like sedation pattern (mimics natural sleep architecture) — distinct from benzodiazepines or z-drugs that disrupt REM sleep.
Trial start
In progressActual: Jun 1, 2025
Phase 2a trial (NCT06685965) initiated and actively recruiting patients with insomnia associated with PTSD. Sublingual dexmedetomidine administration.
Why it matters: First clinical trial targeting PTSD-specific insomnia with sublingual dexmedetomidine. Actively recruiting as of April 2026 — strong execution signal. If successful, addresses major unmet need: ~70-91% of PTSD patients experience sleep disturbance.
Recorded Events
Jun 1, 2025: Trial start
Mar 1, 2025: data-readout
Jan 1, 2025: regulatory-milestone
RE01 (Sublingual DMT + Harmine)
Sublingual formulation combining DMT (N,N-dimethyltryptamine) with harmine (MAO-A inhibitor) for controlled psychedelic experience without IV administration. Targets cocaine and stimulant use disorder. Phase 1 complete with safety and PK data from two trials in healthy volunteers.
Programme Tracker
Substance Use Disorders (SUD)
Phase 1 complete. Two clinical trials conducted (NCT04716335: randomized, double-blind, placebo-controlled safety/tolerability/PK in healthy volunteers; NCT05829603: follow-up study). Four peer-reviewed publications supporting the safety and PK profile. Phase 2 preparation underway for cocaine/stimulant use disorder.
Milestones
Trial start
CompletedActual: Jun 1, 2021
First Phase 1 trial (NCT04716335) initiated: randomized, double-blind, placebo-controlled study of sublingual DMT+harmine in healthy volunteers to establish safety, tolerability, and pharmacokinetic profile.
Why it matters: First clinical evaluation of a sublingual DMT+harmine combination. Sublingual route avoids the intensity and unpredictability of IV DMT while maintaining oral bioavailability via MAO-A inhibition — a significant formulation innovation.
data-readout
CompletedActual: Jan 1, 2023
Phase 1 data published in Frontiers in Pharmacology and International Journal of Neuropsychopharmacology (IJNP). Two additional publications in Biomedicine & Pharmacotherapy. Four total peer-reviewed papers supporting RE01 safety/PK profile.
Why it matters: Four peer-reviewed publications from Phase 1 provide strong evidence base and scientific credibility. Published PK data supports sublingual route as viable alternative to IV DMT with controlled pharmacokinetics.
Trial start
CompletedActual: Jun 1, 2023
Second Phase 1 trial (NCT05829603) initiated for sublingual DMT+harmine, building on first study safety data.
Why it matters: Follow-up Phase 1 expands safety database and refines dosing for Phase 2 design.
Recorded Events
Jun 1, 2023: Trial start
Jan 1, 2023: data-readout
Jun 1, 2021: Trial start
RE02 (Sublingual 5-MeO-DMT)
Sublingual formulation of 5-MeO-DMT for treatment-resistant generalized anxiety disorder (GAD). Phase 1 conducted (NCT05979727) — trial shows "terminated" status on ClinicalTrials.gov, but this may reflect completion or protocol change rather than safety signal, given that the company continues active development.
Programme Tracker
Anxiety Disorders
Phase 1 trial (NCT05979727) listed as "terminated" on ClinicalTrials.gov — status ambiguous; may reflect protocol completion or amendment. Company continues RE02 development. Treatment-resistant GAD is target indication.
Milestones
Trial start
CompletedActual: Jan 1, 2024
Phase 1 trial (NCT05979727) of sublingual 5-MeO-DMT initiated for treatment-resistant generalized anxiety disorder.
Why it matters: First clinical trial of sublingual 5-MeO-DMT formulation. 5-MeO-DMT has shorter duration (~30 min) than psilocybin or DMT, potentially enabling use in standard clinical settings. GAD represents a large underserved market.
Recorded Events
Jan 1, 2024: Trial start
Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase II
- Website
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