Silo Pharma
Preclinical2 active candidates
shared compound: Ketaminesame indication: Chronic Painsame regulator: US FDAsimilar active pipeline size
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Lead program: Approved
Categories
1 domain / 2 areas / 1 specialization
PharmaTherCSE: PHRM
Data updated
2 Drug Candidates1 Trial
Canadian specialty pharmaceutical company focused on ketamine-based therapies for psychiatric and neurological conditions. KETARX™ (racemic ketamine IV) received FDA approval in August 2025, making PharmaTher one of the first Canadian companies to achieve US regulatory approval for a ketamine product. Also developing KETABET, a proprietary combination of ketamine and betaine.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 2
- Active programmes
- 1
- Lead stage
- Approved
- Forecast coverage
- 1 of 1
All tracked candidates active
2 total in tracker
Multiple active stages
1 active programme with forecast fields
Latest sourced update
PharmaTher CEO shareholder letter notes continued evaluation of internal ketamine programs in 2026
Jan 2026 - Press release - PharmaTher - Ketamine (IV) — Levodopa-Induced Dyskinesia
Next known catalyst
Phase II topline
Timing not specified - Ketamine (IV) — Levodopa-Induced Dyskinesia / Ketamine Phase 2 Programme (Parkinson's / LID) — NCT04912115 - Confidence: 50%
6 sources0 pipeline-linked trials0 pipeline-linked papers1 Approved1 Phase II
Development Programmes
2KETARx (Generic Ketamine Injection)
KetamineApproved
Surgical / post-operative pain management
Programme Tracker
Chronic Pain
Primary: US (FDA)
ApprovedCompleted
FDA ANDA #217858 approved August 8, 2025; U.S. commercialisation rights sold December 2025 (upfronts + milestones potentially exceeding $25M)
Milestones
Regulatory approved
CompletedActual: Aug 8, 2025
FDA approved ANDA #217858 — KETARx generic ketamine injection for surgical pain management
Why it matters: KETARx became the first ketamine product specifically indicated for surgical pain management under an ANDA pathway. Following two prior complete response letters (April and October 2024), approval validates PharmaTher's manufacturing quality fixes. U.S. commercialisation rights sold in December 2025 for potential $25M+ in milestone payments.
Licensing deal
CompletedActual: Dec 1, 2025
U.S. commercialisation rights for KETARx sold; deal includes upfronts, sales milestones, profit-sharing potentially exceeding $25M
Why it matters: Monetising the ANDA approval through a licensing/commercialisation deal is the standard exit for smaller companies that win generic approvals. The $25M+ deal provides runway to advance the Parkinson's ketamine programme.
Recorded Events
Dec 1, 2025: Licensing deal
Aug 8, 2025: Regulatory approved
Evidence Links
PharmaTher announces FDA approval of KETARx ketamine
Press release - PharmaTher - Aug 11, 2025 - Verified
Company release dated 2025-08-11 says FDA approved KETARx on 2025-08-08 for indicated uses in surgical pain management.
PharmaTher and Vitruvias enter collaboration agreement for KETARx commercialization
Press release - PharmaTher - Jun 20, 2023 - Verified
Company release announces a collaboration agreement with Vitruvias for commercialization of KETARx racemic ketamine in the US.
Ketamine (IV) — Levodopa-Induced Dyskinesia
KetaminePhase II
Parkinson's disease (levodopa-induced dyskinesia)
Programme Tracker
Neurocognitive Disorders
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline
Phase 2 complete (suspended before planned March 2024 completion); positive results — subanesthetic IV ketamine reduced LID; advancing toward Phase 3, seeking partnership
Milestones
Phase II topline
CompletedActual: Jan 1, 2024
Phase 2 (NCT04912115) topline: subanesthetic IV ketamine reduced levodopa-induced dyskinesia; well tolerated; proceeding toward Phase 3
Why it matters: Levodopa-induced dyskinesia (LID) is a major quality-of-life issue for Parkinson's patients on long-term levodopa therapy, affecting ~50% after 5 years. There is only one approved treatment (amantadine/Gocovri). Positive Phase 2 data from a randomised, double-blind trial positions ketamine as a potential Phase 3 candidate with a large patient population.
Watch next: Phase 3 partnership announcement and trial initiation
Recorded Events
Jan 1, 2024: Phase II topline
Evidence Links
ClinicalTrials.gov NCT04912115 - Ketamine for Levodopa-Induced Dyskinesia
Registry update - ClinicalTrials.gov - Nov 18, 2023 - Verified
Registry lists PharmaTher as sponsor of the Phase 2 ketamine trial for levodopa-induced dyskinesia in Parkinson’s disease.
PharmaTher Announces Positive Topline Results from Ketamine LID Study
Press release - PharmaTher - Apr 27, 2022 - Verified
Company reported positive topline results from low-dose ketamine for levodopa-induced dyskinesia in Parkinson’s disease.
PharmaTher Advances Phase 3 FDA Package for Ketamine in LID-Parkinson’s Disease
Press release - Newsfile / PharmaTher - Oct 16, 2025 - Verified
Recent update describes FDA package work and Phase 3 readiness activities, contingent on FDA alignment and partnering/financing.
PharmaTher CEO shareholder letter notes continued evaluation of internal ketamine programs in 2026
Press release - PharmaTher - Jan 1, 2026 - Verified
Company 2026 shareholder letter indicates PharmaTher is still assessing internal ketamine programs and ketamine-related opportunities for advancement.
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Quick Facts
- Type
- Public Biotech
- Founded
- 2019
- Ticker
- CSE: PHRM
- Lead Stage
- Approved
- Website
- Visit