SCF API DEVELOPMENT PIPELINE INITIATED
AMX-B01 — Geniposide-Enriched Purified Botanical API
Program: PROJECT AMMONEX-HE
Candidate: AMX-B01
API Class: Purified Botanical-Derived API
Lead Marker: Geniposide
Source: Genipa americana
Indication: Hepatic encephalopathy ammonia modulation
PHASE 0 DELIVERABLE
Pipeline Charter & Development Scope
Document Code: SCF-AMMONEX-HE-AMXB01-P0-0001
0.1 Development Objective
Develop AMX-B01, a geniposide-enriched purified botanical-derived API, as an oral hepatoenteric nitrogen-homeostasis modulator for hepatic encephalopathy.
Primary therapeutic objectives:
Objective | Priority |
Support hepatic nitrogen metabolism | Critical |
Reduce ammonia-associated systemic burden | Critical |
Stabilize gut–liver inflammatory signaling | High |
Protect against neuroimmune amplification | High |
Maintain botanical API reproducibility | Critical |
0.2 SCF Strategic Rationale
AMX-B01 is positioned as the hepatic metabolic restoration arm of AMMONULIN™-B, using purified geniposide as the primary marker compound. The candidate aligns with SCF requirements for targeted drug action, pharmacokinetic optimization, metabolic efficiency, resistance prevention, and safety profile optimization.
0.3 Regulatory Development Scope
FDA-Aligned Area | Required AMX-B01 Output |
Botanical source control | authenticated Genipa americana source dossier |
API identity | geniposide marker specification |
CMC | extraction, purification, release, stability |
Nonclinical pharmacology | HE ammonia-axis pharmacology package |
ADME/PK | oral exposure and hepatic distribution |
Toxicology | IND-enabling safety package |
IND readiness | Module 3, Module 4, and Phase I protocol support |
IND development must support human exposure with adequate CMC, nonclinical, and clinical protocol information.
0.4 Pipeline Phase Map
Phase | Deliverable | Trigger |
Phase 0 | Pipeline Charter & Development Scope | INITIATE |
Phase 1 | Botanical Source Qualification | SOURCE QUALIFY |
Phase 2 | Extraction & Purification Blueprint | EXTRACT API |
Phase 3 | API Characterization & Release Specifications | CHARACTERIZE |
Phase 4 | MoA/MeA Pharmacology Package | PROFILE API |
Phase 5 | ADME/PK & Formulation Engineering | PK BUILD |
Phase 6 | Preclinical Efficacy Program | EFFICACY PLAN |
Phase 7 | IND-Enabling Toxicology | TOX PLAN |
Phase 8 | CMC IND Package | CMC IND |
Phase 9 | Pre-IND Briefing Package | PRE-IND |
Phase 10 | IND/FIH Readiness Package | FIH READY |
0.5 Phase 0 Decision Gate
Status: Proceed to Phase 1.
Required Next Trigger:
SOURCE QUALIFY
MASTER REGISTRY INDEX
SCF-AMMONEX-HE-AMXB01-P0-0001 — Pipeline Charter
SCF-AMMONEX-HE-AMXB01-API-0002 — Geniposide-Enriched API Program
SCF-AMMONEX-HE-BOT-0003 — Botanical Source Control
SCF-AMMONEX-HE-IND-0004 — IND Translation Pathway