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Lead program: Phase II
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Research, Drug Development & Manufacturing

Freedom Biosciences

Data updated

New Haven, CT / Yale University spin-out, USA, United States
1 Drug Candidate

Freedom Biosciences is a Yale University spin-out developing next-generation combination therapies for treatment-resistant depression. Co-founded by Yale psychiatry chair Dr. John Krystal (CSO) and Dina Burkitbayeva (CEO, PsyMed Ventures), the company raised $10.5M seed financing in August 2022. Its lead asset FREE001 combines ketamine with temsirolimus (an mTOR inhibitor and prodrug of sirolimus) to extend the antidepressant duration of ketamine from the standard 2–7 days to approximately 14 days. FDA cleared the IND for the Phase 2a study in April 2024, and the trial (FREE001-TRD-201, n≥100) is underway.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
1

All tracked candidates active

Active programmes
1

All tracked programmes active

Lead stage
Phase II

Current furthest stage

Forecast coverage
1 of 1

1 active programme with forecast fields

Latest sourced update

Freedom Biosciences - Pipeline

Jun 26, 2026 - company-website - Freedom Biosciences - FREE001 (Ketamine + Temsirolimus)

Next known catalyst

Phase II topline

Timing not specified - FREE001 (Ketamine + Temsirolimus) / FREE001-TRD-201 Phase 2a (TRD) — FDA IND - Confidence: 50%

3 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

1

FREE001 (Ketamine + Temsirolimus)

Ketamine
Phase II
Treatment-Resistant Depression (TRD)

Treatment-resistant depression — IV ketamine combined with mTOR inhibitor temsirolimus to extend antidepressant response from ~2-7 days to ~14+ days

Programme Tracker

Treatment-Resistant Depression (TRD)

Primary: US (FDA)
Phase IIActive

Forecast

Phase II topline

Phase 2a dose-ranging trial underway (~100 patients) since H1 2024. FDA IND approved April 2024. Data readout expected ~2026. Yale spinout co-founded by Dr. John Krystal (Chair of Psychiatry, Yale). Total funding ~$10.5M.

Milestones

Phase II started

Completed

Actual: Jun 1, 2024

Phase 2a dose-ranging study initiated (~100 patients)

Why it matters: Trial enrollment begun — evaluating safety, tolerability, PK, and efficacy signals across dose ranges. ~100 patients is a substantial Phase 2a for an academic spinout, suggesting confidence in the mechanism.

Watch next: Enrollment completion and first efficacy data

Freedom Biosciences Announces FDA Approval of IND Application for FREE001(Press release)[Verified]Freedom Biosciences - Pipeline(company-website)[Verified]

Regulatory review accepted

Completed

Actual: Apr 1, 2024

FDA approved IND application for FREE001-TRD-201 Phase 2a in treatment-resistant depression

Why it matters: IND clearance validates the combination approach (ketamine + mTOR inhibitor) as safe enough for human trials. If temsirolimus extends ketamine's antidepressant effects from ~1 week to ~2+ weeks, it would reduce the frequency of IV infusions — the main practical barrier to chronic ketamine treatment for TRD.

Watch next: Phase 2a data readout expected ~2026

Freedom Biosciences Announces FDA Approval of IND Application for FREE001(Press release)[Verified]

Funding milestone

Completed

Actual: Aug 1, 2022

Emerged from stealth with $10.5M seed financing

Why it matters: Freedom Biosciences is a Yale spinout co-founded by John Krystal (Chair of Psychiatry, Yale — one of the world's foremost ketamine researchers) and Dina Burkitbayeva (PsyMed Ventures). The $10.5M seed funds the Phase 2a programme. The scientific premise is validated by Yale academic data (NCT02487485) showing mTOR inhibition extends ketamine's antidepressant window.

Freedom Biosciences emerges from stealth with $10.5M seed financing(Press release)[Verified]

Recorded Events

Jun 1, 2024: Phase II started

Apr 1, 2024: Regulatory review accepted

Aug 1, 2022: Funding milestone

Evidence Links

Freedom Biosciences - Pipeline

company-website - Freedom Biosciences - Jun 26, 2026 - Verified

Current company site lists FREE-001 as an extended-efficacy ketamine programme for treatment-resistant depression with Phase 2 placement.

Freedom Biosciences Announces FDA Approval of IND Application for FREE001

Press release - PR Newswire - Apr 25, 2024 - Verified

FDA notified Freedom that it may proceed with FREE001-TRD-201, a Phase 2a dose-ranging evaluation in adults with TRD.

Freedom Biosciences emerges from stealth with $10.5M seed financing

Press release - Freedom Biosciences / BioSpace - Aug 23, 2022 - Verified

Release reports $10.5M seed financing to advance lead ketamine and other exploratory psychedelic programmes.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
Neurocentrx
Phase II1 active candidate
shared compound: Ketaminesame indication: Treatment-Resistant Depression (TRD)Phase II peersimilar active pipeline size
AtaiBeckley
Phase II4 active candidates2 trials1 paper
same indication: Treatment-Resistant Depression (TRD)Phase II peersame regulator: US FDAsame country: United States
Clexio Biosciences
Phase II2 active candidates1 trial
same indication: Treatment-Resistant Depression (TRD)Phase II peersame regulator: US FDAsimilar active pipeline size
Tasman Therapeutics
Phase III2 active candidates
shared compound: Ketaminesame indication: Treatment-Resistant Depression (TRD)same regulator: US FDAsimilar active pipeline size

Quick Facts

Type
University Spinout
Founded
2022
Lead Stage
Phase II
HQ
New Haven, CT / Yale University spin-out, USA, United States
Website
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