Belcopa
Multiple-sclerosis symptomology Research concept — protocol development
Concept
Ethics
Pilot
Controlled
Validate
Scale
Development architecture
Our Pipeline
Two lead concepts are moving through different scientific and regulatory pathways under one evidence standard.
BELCOPA
CONCEPT
ETHICS
PILOT
CONTROLLED
VALIDATE
SCALE
NOVUSCLARUS
DOSSIER
FORMULATION
PRE-IND
PHASE 1
PHASE 2
REVIEW
TWO DISTINCT DEVELOPMENT PATHSShared standards for evidence, consent, safety, and transparency.
NovusClarus
Multiple-sclerosis symptomology Investigational product concept — preclinical planning
Dossier
Formulation
Pre-IND
Phase 1
Phase 2
Review
Program comparison
Shared rigor, different evidence needs.
The pipeline is designed to prevent a behavioral protocol and a controlled-substance combination product from being represented as if they face the same development questions.
| Program | Intervention type | Current evidence | Near-term work | Material uncertainty | Status |
|---|---|---|---|---|---|
| Belcopa Practitioner-mediated behavioral intervention | Context, consent, ritual, and symptom interpretation | Conceptual rationale; no pilot dataset | Ethics review, protocol fidelity, comparator and debriefing design | Whether the intervention produces measurable benefit under informed conditions | Protocol development |
| NovusClarus 50 mg MDMA + 500 mg acetaminophen | Once-weekly fixed-dose pharmaceutical concept | Single-subject low-dose MDMA case; combination not directly tested | Source-data audit, CMC feasibility, safety strategy, pre-IND planning | Component contribution, dose, safety, indication, and efficacy | Preclinical planning |
Development gates
No program advances on narrative alone.
Each gate requires documented evidence, independent review, and a recorded decision.
Scientific Dossier
Source records, literature, mechanism, confounders, and open questions.
Ethics & Safety
Consent, exclusions, monitoring, aftercare, privacy, and risk governance.
Feasibility
Manufacturing, sourcing, protocol delivery, site capacity, and cost.
Controlled Evidence
Prospective endpoints, comparators, component analysis, and independent statistics.
Regulatory Decision
Proceed, redesign, pause, partner, license, or discontinue.