Mydecine Innovations
Phase II2 active candidates
2 shared indicationsPhase II peersame regulator: US FDAsimilar active pipeline size
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Lead program: Phase II
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1 domain / 2 areas / 1 specialization
Reconnect Labs
Data updated
3 Drug Candidates2 Trials
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.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 3
- Active programmes
- 3
- Lead stage
- Phase II
- Forecast coverage
- 3 of 3
All tracked candidates active
All tracked programmes active
Multiple active stages
3 active programmes with forecast fields
Latest sourced update
Reconnect Labs Clinical Pipeline
Jun 27, 2026 - company-website - Reconnect Labs - RE01 (Sublingual DMT + Harmine)
Next known catalyst
Phase II topline
Q4 2026 - RE03 (Sublingual Dexmedetomidine) / RE03 — Phase 2a Insomnia in PTSD (NCT06685965) - Confidence: 55%
11 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase II2 Phase I
Development Programmes
3RE03 (Sublingual Dexmedetomidine)
Phase II
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
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline - Likely: Q4 2026
RE03 Phase 2a is recruiting in PTSD-related sleep disturbance. Reconnect announced first patient enrollment on 2025-10-20, and ClinicalTrials.gov lists estimated study completion in August 2026.
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
Evidence Links
ClinicalTrials.gov NCT06685965 - RE03 in PTSD Sleep Disturbance
clinical-trial-registry - ClinicalTrials.gov - Sep 16, 2025 - Verified
Registry lists a recruiting Phase 2 study of RE03 in PTSD patients with sleep disturbances, sponsored by Reconnect Labs.
Reconnect Labs - Clinical Pipeline
company-website - Reconnect Labs - Jun 26, 2026 - Verified
Pipeline page describes RE03 sleep-architecture data and the PTSD sleep-disturbance programme.
Effects of Subanesthetic Oromucosal Dexmedetomidine on Sleep in Healthy Volunteers
Publication - PubMed Central - Feb 20, 2025 - Verified
Publication reports randomized placebo-controlled crossover studies of oromucosal dexmedetomidine sleep effects, supporting RE03 formulation rationale.
RE01 (Sublingual DMT + Harmine)
Phase I
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)
Primary: Switzerland (Swissmedic)
Phase IActive
Forecast
Phase II started - Likely: Q1 2027
Phase 1 studies NCT04716335 and NCT05829603 are complete, with peer-reviewed DMT/harmine formulation data published. Reconnect still lists RE01 for cocaine and stimulant use disorder, and a March 2026 company release highlighted RE01 as a controllable, scalable psychedelic architecture.
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
Evidence Links
ClinicalTrials.gov NCT04716335 - DMT and Harmine Neurodynamics Study
clinical-trial-registry - ClinicalTrials.gov - Oct 4, 2022 - Verified
Completed early Phase 1 study of DMT and harmine in healthy subjects, supporting the RE01 evidence base.
ClinicalTrials.gov NCT05829603 - Dose-Finding Study of DMT and Harmine
clinical-trial-registry - ClinicalTrials.gov - Nov 2, 2023 - Verified
Completed Phase 1 dose-finding study comparing DMT and harmine PK/PD profiles in healthy subjects.
Overcoming the Clinical Challenges of Traditional Ayahuasca
peer-reviewed-publication - Frontiers in Pharmacology - Nov 27, 2023 - Verified
First-in-human publication exploring buccal/intranasal DMT and harmine administration approaches.
Reconnect Labs Clinical Pipeline
company-website - Reconnect Labs - Jun 27, 2026 - Verified
Company pipeline lists RE01 as a fixed-combination DMT/harmine candidate for cocaine and stimulant use disorder.
RE02 (Sublingual 5-MeO-DMT)
Phase I
RE02 is Reconnect's patented, precision-formulated sublingual 5-MeO-DMT / 5-HT1A-focused anxiolytic programme for treatment-resistant generalized anxiety disorder. ClinicalTrials.gov lists the Phase 1 registry NCT05979727 as terminated after 4 participants, while the current Reconnect pipeline continues to list RE02 with Phase 2a in GAD as the next-step focus.
Programme Tracker
Anxiety Disorders
Primary: Switzerland (Swissmedic)
Phase IActive
Forecast
Phase II started - Likely: Q2 2027
The Phase 1 RE02 registry remains listed as terminated after 4 participants. Reconnect's current pipeline still describes RE02 as a rapid-acting, non-addictive anxiolytic for treatment-resistant GAD, so the next action is company clarification of Phase 1 outcome and Phase 2a timing.
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
Evidence Links
ClinicalTrials.gov NCT05979727 - Dose-Finding PK/PD Trial for RE02
clinical-trial-registry - ClinicalTrials.gov - Nov 27, 2024 - Verified
Registry record for the Phase 1 RE02 study in healthy subjects; ClinicalTrials.gov lists it as terminated after 4 participants.
Reconnect Labs Clinical Pipeline
company-website - Reconnect Labs - Jun 26, 2026 - Verified
Company pipeline continues to list RE02 and describes treatment-resistant generalized anxiety disorder as its next-step focus.
Safety and Tolerability of Multiple Sublingual Microdoses of 5-MeO-DMT
peer-reviewed-publication - PubMed - Jan 1, 2025 - Verified
Publication supports the broader sublingual 5-MeO-DMT development rationale relevant to RE02.
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Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase II
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