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Arrayán Bioscience GMP Platform

Arrayán Bioscience GMP platform in Uruguay: technology, raw-material routes, product line, regulation, roadmap and capital structure.

Arrayán Bioscience · Montevideo

GMP ibogaine production platform with several raw material routes

The project builds an end-to-end platform in Uruguay: from genetics and plant raw materials to single-stage conversion, quality control, GMP certification and API export.

Investment profile · May 2026

Seed round
$2 million
SAFE · round open
Pre-money
$6 million
Seed-round terms
Supply routes
3
Operational routes A, B and C
Raw material options
4
Additional option D is being monitored.

Market shortage

Demand emerges before standardized supply is available.

There is no manufacturer of GMP-grade ibogaine for human use. Clinics receive alkaloids from the gray market without full quality control and traceability.

0

commercial manufacturers of GMP ibogaine for use in humans

Tabernanthe iboga · Africa
CITES, geopolitical risks, and a 6–8-year cultivation cycle
Voacanga africana · Direct supply
Gray market, lack of GMP and uncontrolled alkaloid profile
Biosynthesis
Promising academic results, but no readiness for commercial GMP production
Complete chemical synthesis
More than five stages and a cost of over $10,000/g

Brief overview

What is ibogaine

Ibogaine is a psychoactive indole alkaloid found primarily in the bark of the roots of the West African shrub Tabernanthe iboga. It is classified as an atypical psychedelic: it interacts with several neurotransmitter systems at once and causes a prolonged sleep-like state of consciousness.

The pharmacological profile of ibogaine is complex and not yet fully understood. The main clinical interest is related to disorders caused by substance use; in parallel, the effects of traumatic brain injury and associated mental symptoms are investigated.

Substance class
Indole alkaloid
Formula
C₂₀H₂₆N₂O
Natural source
Tabernanthe iboga

Research focus

Clinical directions of the project

Ibogaine is currently considered an investigational molecule. The directions below reflect areas of scientific interest rather than a list of proven medical indications.

  1. Opioid disorder

    The main historical focus

    Ibogaine is being investigated as a drug that can affect withdrawal symptoms and cravings. Controlled clinical trials are needed to confirm efficacy and safety.

  2. Alcohol and stimulant dependence

    Early clinical programs

    In 2026, the FDA authorized a phase I study of noribogaine hydrochloride for alcohol use disorder in the United States.

  3. Consequences of traumatic brain injury

    Observational study

    The open-label Nature Medicine study involved 30 male veterans predominantly with mild TBI. After therapy, measures of functioning improved, but there was no control group.

  4. PTSD, depression and anxiety

    Secondary results of the study

    The same participants had reduced symptoms after a month. The authors emphasize that initial results must be confirmed by controlled trials.

Open sources

Platform architecture

Four raw-material options without a single point of failure

Three operational raw-material streams and one monitored option converge in one laboratory, one quality-control process and one export infrastructure.

  1. A 0-6 months

    Voacangine from Ghana

    No additional CAPEX is required.

    • Available without waiting for cultivation
    • Confirmed GMP source
    • Conversion covered by DMF Bruno

    Risk: Supply-chain dependence on a single region

    Baseline Route 0 for the Seed round

  2. B 4 years

    Voacanga Plantation · Bahia

    Base CAPEX of $300,000–500,000

    • Full control of the supply chain
    • Cost of about $10–20/kg versus $70/g for imports
    • Bahia's tropical climate

    Risk: Four years before the first commercial harvest

    Vertical Integration in Series A or B

  3. C 18-24 months before the pilot

    T. catharinensis + C. roseus

    Base CAPEX of $150,000–250,000

    • Both plants are already in Uruguay.
    • The non-destructive cycle of C. roseus is 3–4 weeks
    • Coronaridine increased tenfold at 35 °C

    Risk: The new semisynthetic route requires pilot validation

    Innovative route and potential IP

  4. D Observation

    Amazonian Voacangine

    No additional CAPEX is required.

    • No current investment required
    • When scaled up, it can become the cheapest natural source.
    • Complements Route B's timeline

    Risk: Commercial scalability has not been proven

    Decision on whether to proceed in 2027

Two CAPEX scenarios. The revised scenario calls for about $460,000 for Route B and $320,000 for Route C; base ranges are $300,000 to $500,000 and $150,000 to $250,000, respectively.

Basic chemical route

One conversion stage and a single GMP workflow

Route A uses GMP voacangine from Ghana and an active DMF from Bruno. This is the basic Seed Round route and the launch option without waiting for plant cultivation.

  1. 01 Voacangine HCl GMP · Ghana
  2. 02 Single-stage conversion
  3. 03 Ibogaine HCl
  4. 04 Quality control and CoA
  5. 05 GMP certification and export
Efficiency
>95%
conversion of voacangine to ibogaine
Raw materials
$70/g
confirmed non-GMP voacangine
GMP raw materials
about $120/g
benchmark for GMP voacangine
API yield
about 500 g
from 1 kg of raw materials, based on mass ratio and extraction efficiency
Ibogaine HCl GMP
$1,000–1,250/g
target price range
Gross margin
>70%
estimate before overhead costs

Local raw-material supply

Two Uruguayan Plants for Route C

Route C shifts part of the raw-material supply base to Uruguay. Both plants are already present in the country and can be processed using the same laboratory equipment and process.

Tabernaemontana catharinensis

leiteira

It's native to Uruguay. The root bark contains the CIVI complex: coronaridine, voacangine, ibogaine and ibogamine.

  • Coronaridine – 0.5%; voacangine – 0.4%
  • About 1.2% total alkaloids with methanol extraction
  • Published benchmark for crude extract – $191/kg
  • Co-product: coronaridine at $80–150/mg

Catharanthus roseus

Periwinkle

It is an ornamental plant already grown in Uruguay. The greenhouse model is designed for continuous rotation with low capital costs.

  • Non-destructive leaf collection
  • 3–4-week cycle
  • According to 2024 data, the coronaridine yield increased tenfold at 35 °C.
  • Co-product: catharanthine at $20–80/mg

A single-stage process allows the conversion of coronaridine and voakangin from the raw extract of T. catharinensis into ibogaine.

Product line

Five APIs from a single production base

One lab is designed to produce five related APIs for pharmaceutical and research customers.

  1. 01

    Ibogaine HCl

    $1,000–1,250/g

    Primary GMP API; no GMP source is currently available on the market.

    Customers: Pharmaceutical companies, CROs and clinics

  2. 02

    Coronaridine

    $80-150/mg

    Product of the T. catharinensis and C. roseus routes; no large-scale suppliers.

    Customers: Drug discovery, 18-MC synthesis, universities

  3. 03

    Voacangine

    $70/g

    Ibogaine precursor and separate revenue source during scaling.

    Customers: Synthetic laboratories and the research market

  4. 04

    18-MC

    Emerging market

    Semisynthesized from coronaridine; a clinical product without cardiotoxicity.

    Customers: Pharmaceutical programs against addiction

  5. 05

    Noribogaine

    $50-120/mg

    Active metabolite of ibogaine with independent clinical interest.

    Customers: DemeRx, Delix and Pharmacokinetic Laboratories

Why Uruguay

A regulatory model the project considers difficult to replicate quickly

The project ties its competitive advantage not only to the chemical process, but also to the legal status of the molecule, clinical trial and export certification.

Legal status
Ibogaine is not listed on Uruguayan lists of banned substances.
API authorization
Pharmaceutical substances require GMP certification, but not separate registration as a medicinal product.
Clinical study
The MSP and the National Ethics Committee approved the Arché/UdelaR ibogaine study on May 5, 2026.
Export pathway
The GMP certificate should make it possible to obtain a certificate of free sale for export to the United States, Canada, Australia, New Zealand and Mexico.
Institutional environment
Uruguay is among the world's 15 most fully democratic countries and remains resilient as administrations change.
Parties involved
The project involves the police union, the Ministry of the Interior and the Ministry of Health.

Roadmap

From the first batches to a vertically integrated platform

The strategic roadmap shows year-by-year targets, and the operating calendar clarifies the timing of construction, authorization and first contracts.

Strategic road map

  1. 2026

    Route A launched

    Voacangine from Ghana, Centro Flora, first batches and API authorization in Uruguay

  2. 2027

    Pilot routes B and C

    Quantitative assessment of T. catharinensis, a C. roseus greenhouse, a site in Bahia and pilot conversion of coronaridine → ibogaine

  3. 2028

    GMP laboratory at full capacity

    Company-owned certified facility, revenue of $3.36 million, positive EBITDA and first contracts in the United States, Canada and Australia

  4. 2029

    Multi-route platform

    Capacity of 75 kg/year, three export markets, development of 18-MC and noribogaine

  5. 2030

    A key supplier in Latin America

    First Voacanga crop, full vertical integration, revenue of $6.74 million and EBITDA of 58%

Operating calendar

  1. Q3 2026–Q3 2027

    Construction of a GMP laboratory

    Construction work, equipment and GMP certification · $1 million

  2. Q4 2027–Q1 2028

    API authorization

    Accelerated track through Arché/UdelaR study

  3. Q2 2028

    First export contracts

    USA, Canada, Australia and New Zealand

  4. 2028

    Break-even

    Revenue $3.36 million, EBITDA $1.47 million, Series A trigger at $20–35 million

Project financial outlook

Breakeven in 2028 and ARR $6.74 million by 2030

The financial model sets two checkpoints: breaking even in 2028 and scaling the platform by 2030.

2028

Revenue/ARR
$3.36 million
EBITDA margin
About 44%

EBITDA: +$1.47 million

First profitable year and first export contracts

2030

Revenue/ARR
$6.74 million
EBITDA margin
58%

EBITDA: Absolute value not disclosed

ARR as volumes grow and the multi-route platform develops

Competitive landscape

Arrayán's competitive position

Arrayán combines Uruguay’s manufacturing base, export readiness and four raw material supply options.

Positioning of Arrayán Bioscience and other market participants
Participant GMP status Latin American base Exports Routes Raw material base
Arrayán Bioscience Under construction Uruguay Yes. A+B+C+D Local plants + GMP
ATAI Life Sciences No. No. Research One. Dependence on Africa
DemeRx · United States Phase 2 No. No. One. import
Potential players Unknown. No. Unknown. Unknown. No plan.
Gray market No. Different countries Illegal No. No.
Regulatory advantage
Ibogaine is not scheduled in Uruguay; the API does not require registration as a drug, and the clinical trial is conducted through UdelaR.
Raw-material supply redundancy
Ghana, native plants in Uruguay and a future plantation in Brazil converge in the same laboratory and reduce dependence on a single supply chain.

Capital structure

Capital is tied to milestones rather than being deployed upfront

The financial plan includes two confirmed rounds and an optional Series B. Each next stage is associated with a specific project milestone.

Seed · Round 0

$2 000 000

SAFE · pre-money $6 million

Trigger: Round is open

  • Construction of GMP - $1,000,000
  • Team for 18 months - $400,000
  • Legal support and IP – $150,000
  • Business Development and Reserve: $450,000
  • Bruno partnership – additional $350,000, optional

F1: API authorization and at least one export contract

Series A · Round 1

$3.5 million to $5 million

Priced equity · pre-money $20-35 million

Trigger: API authorization and at least one contract

  • Scaling up GMP
  • Routes B and C
  • Bahia plantation and operations
  • International Business Development in the USA, EU and Australia
  • IP Extension and IND Filing

F2: First API export contract signed

Series B · Optional

$12-17 million

Pre-money $75 million to $100 million

Trigger: Only if an exit has not occurred by F2–F3

  • Fully operational plantation in Bahia
  • MDMA and psilocybin lines, new APIs
  • IND filing in the US and EU
  • Strategic Pharmaceutical or PE Partner

Probable scenario: a strategic exit at F2/F3 makes this round unnecessary

A parallel non-dilutive funding channel includes NIH, MAPS, ANII, EU Horizon, and Texas EO, with an additional $250,000 to $1 million available alongside the rounds.

Catalysts and exit scenarios

Three time horizons for strategic exit

Regulatory decisions, industry deals, and expanding access form a window for capital raising and three exit scenarios.

Key catalysts

  1. April 18, 2026

    Federal momentum in the US

    A U.S. presidential executive order on ibogaine provides for $50 million in federal co-financing.

  2. May 5, 2026

    Approval of a clinical trial

    The MSP has approved the UdelaR clinical trial; the project sees this decision as an accelerating factor for API authorization.

  3. 2024

    Comparable transaction

    AbbVie's $65 million deal for seed-stage psychoplastogen rights without clinical data serves as an industry benchmark for valuation.

  4. 2023–2025

    Regulatory movement in Oceania

    Decisions by Australia and New Zealand on MDMA and psilocybin are increasing the priority of GMP supply.

Exit scenarios

  1. $20-55 million

    F2–F3 · 2027–2028

    Strategic exit

    Strategic M&A: acquisition of a GMP supply chain and a Uruguayan regulatory position.

  2. $60-$150 million

    F3–F4 · 2029–2030

    Revenue-based exit

    Revenue-based exit at ARR of $6 million: IPO or recapitalization with PE.

  3. $100–300 million+

    F4 · from 2030

    Platform exit

    Platform valuation with its own pipeline and a position as a key supplier in Latin America.

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