Zelira Therapeutics

What Zelira Therapeutics does

Zelira Therapeutics Limited is an Australian-listed biopharmaceutical company (ASX: ZLD; OTCMKTS: ZLDAF) headquartered in Perth that develops and commercializes proprietary, clinically validated cannabinoid-based medicines. The company originated as Zelda Therapeutics (formerly Zelda Therapeutics Pty Ltd), debuted on the ASX in November 2016, and rebranded to Zelira Therapeutics. It is led by Chairman Osagie Imasogie (co-founder of PIPV Capital, with senior leadership experience at SmithKline Beecham, DuPont Merck, and Endo Pharmaceuticals) and Global CEO Dr. Oludare Odumosu (former COO of Ilera Healthcare, CSO/EVP at TerrAscend Corp). The company operates with a reported 1–10 employees across offices in Perth, with market presence in Australia, the United States (Louisiana, Washington DC), the United Kingdom, Germany, and select EU jurisdictions.

The company's portfolio spans three commercial categories. First, prescription (Rx) cannabinoid medicines including Zenivol/ZTL-101 (a Phase 1b/2a-validated insomnia formulation approved under Australia's TGA Special Access Scheme), ZTL-103 (a chronic non-cancer pain formulation that completed Phase 1 dose escalation in opioid-dependent patients), and the HOPE range for autism spectrum disorder. Second, HOPE 1 — the company's lead clinical-stage asset targeting Phelan-McDermid Syndrome — is advancing through FDA Phase 2 and Phase 3 trials under a Special Purpose Vehicle (SPV) structure. Third, consumer/OTC products include a hemp-derived oral care line launched via a wholly-owned subsidiary in partnership with Sprinjene, and a dermatology line (RaffiVe). Underlying technology includes proprietary full-spectrum cannabis extracts (using the entourage effect hypothesis), an EDCDM Enhanced CBD Absorption Technology developed with Curtin University, and a diabetic nerve pain drug candidate compared head-to-head against Lyrica (pregabalin) with top-line results released in June 2023.

Zelira's revenue model is a hybrid of licensing royalties from regional distribution partners (US, Australia, EU), direct product sales of Rx medicines through the TGA Special Access Scheme and pharmacy channels, OTC consumer product sales, and SPV-funded clinical development capital. Reported revenue has collapsed from approximately AUD $1.54M (2022) to AUD $656 (2025), while the company has raised cumulative disclosed capital exceeding AUD $50M including an A$8.75M placement (August 2020), US$8.6M from Cantheon Capital (February 2023), and US$32.98M from ThirdGate Capital (January 2026) — the latter at a US$65.96M post-money SPV valuation. The operating posture reflects a deliberate transition from low-revenue commercialization toward FDA-regulated drug development, with the HOPE 1 SPV as the primary economic engine.

Name

Zelira Therapeutics

Legal name

Zelira Therapeutics Limited

Website

https://zeliratx.com

Company type

Public

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Zelira Therapeutics is an Australian-listed biopharmaceutical company that develops and commercializes clinically validated cannabinoid-based medicines for insomnia, autism spectrum disorder, chronic pain, and Phelan-McDermid Syndrome, distributing through Rx, OTC, and licensing channels in the US, Australia, UK, and EU.

Ownership category

akta.pro rank

Product category

Cannabinoid-based biopharmaceuticals

NAICS

Medicinal and Botanical Manufacturing (325411), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Medicinal Chemicals & Botanical Products (2833), Pharmaceutical Preparations (2834)

akta.pro primary industry

CBD/Hemp Wellness & Supplements Retail (CRANAHAC)

akta.pro secondary industries

Sleep, Stress & Mood Support (HLAIADAG), CBD/Hemp Topicals & Beauty Retail (CRANAHAB)

Keywords

• Cannabinoid-based medicines
• Medicinal cannabis products
• Clinical drug development
• Biopharmaceutical products
• Prescription therapeutics

Headquarters

HQ city

Perth

HQ country

Australia

HQ region

Oceania

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Licensing Payments: Revenue generated from licensing proprietary formulations and technologies to distribution partners in regulated markets
2. Royalties: Ongoing royalty payments from licensed products sold in various jurisdictions including US, Australia, and European markets
3. Product Sales (Rx and OTC): Direct sales of prescription medicines (Zenivol for insomnia) and consumer/OTC products (dermatology, oral care) through pharmacy and healthcare networks
4. SPV Capital Raises: Special Purpose Vehicle funding structure for HOPE 1 drug candidate development, with ThirdGate Capital taking 50% stake in SPV valued at US$65.96M

Go-to-market motion3 records

Distribution channels5 records

Marketing channels6 records

Core offering

Zelira Therapeutics develops and commercializes proprietary cannabinoid-based medicines for conditions including insomnia, autism-related conditions, chronic pain, and diabetic nerve pain. Its current portfolio spans branded prescription products, clinical-development candidates, and consumer oral-care and dermatology products.

Product overview

Zelira Therapeutics is a global biopharmaceutical company developing and commercializing clinically validated cannabinoid-based medicines. The portfolio spans three main categories: Prescription (Rx) medicines targeting specific medical conditions including insomnia (Zenivol, ZTL-101), autism spectrum disorder (HOPE™), chronic non-cancer pain (ZTL-103, diabetic nerve pain drug), and Phelan-McDermid Syndrome (HOPE 1 in clinical development); Consumer/OTC products including oral care and dermatology lines; and pre-clinical assets in cancer research. The company employs a 'Launch, Learn & Develop' model to fast-track commercialization while building clinical evidence.

Differentiator

Problem solved

Functional benefit

Products and services

• Zenivol Proprietary cannabinoid medicine for chronic insomnia, clinically validated in Phase 1b/2a trials with safety and a statistically significant reduction in chronic insomnia, and available in Australia under the TGA Special Access Scheme.
• HOPE™ Range of cannabinoid-based products for autism spectrum disorder, available in US medical-cannabis markets including Louisiana and Washington DC.
• Oral Care Products Hemp-derived cannabinoid-based oral care products, beginning with a proprietary toothpaste formulation developed with Sprinjene CEO Dr Sayed Ibrahim, and available in the United States and United Kingdom through the Sprinjene platform.
• Dermatology Products Consumer skincare products containing cannabinoids, available in the United States.

Quantifiable outcome

• Statistically significant reduction in Insomnia Severity Index (ISI) scores in Phase 1b/2a trial
• +2 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles8 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered major, minor and core.

• Health House International LimitedmajorStrategic or Co-development Partner · 24 February 2022Acquisition target to expand distribution capabilities and strengthen presence in European cannabis market. Provides access to regulated markets, GMP manufacturing facilities, and enhanced clinical trial capabilities. Deal includes $1.5 million loan facility.
• Curtin UniversityminorStrategic or Co-development Partner · 25 August 2021Research partnership demonstrating significant uptake of CBD into the brain using proprietary technology. Channel 9 News coverage of CBD brain absorption research findings.
• Levin HealthminorStrategic or Co-development Partner · 7 June 2021Partnership for upcoming chronic pain clinical trial. Collaboration on development of cannabinoid-based treatments for sports-related chronic pain conditions.
• EmyriacoreStrategic or Co-development Partner · 9 November 2020Partnership for autism spectrum disorder clinical trial using disruptive trial methodology. Combines Emyria's data platform capabilities with Zelira's cannabinoid formulation expertise.
• SprinjeneminorOEM/ Whitelabel/ Licensing Partner · 8 September 2020Formation of oral care products subsidiary to commercialise hemp-derived cannabinoid-based oral care products in USA. First product: proprietary toothpaste formulation developed by Sprinjene CEO Dr Sayed Ibrahim.
• Ilera HealthcaremajorStrategic or Co-development Partner · 11 March 2019Acquisition completed 2019 to establish US manufacturing and distribution presence. Part of strategy to globalise product portfolio and gain vertical integration in supply chain.
• St Vincent's Hospital MelbournecoreStrategic or Co-development Partner · 26 November 2018Clinical trial partnership examining potential of cannabinoid medications for patients on chronic, high-dose opioid pain management therapy. Phase 1 dose escalation trial site for ZTL-103 formulation.
• Telethon Kids InstitutecoreStrategic or Co-development Partner · 5 December 2016Collaboration agreement for paediatric brain cancer research using proprietary cannabinoid formulations. Prestigious research institution providing clinical trial infrastructure and scientific expertise.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Emerging players

• Charlotte's Web: Charlotte's Web is a leading CBD wellness brand with topical, oral, and sleep-positioned consumer products—comparable consumer/OTC wellness and supplement positioning to Zelira's dermatology, oral care, and sleep franchises.

Broad incumbents

• Jazz Pharmaceuticals: Jazz Pharmaceuticals acquired GW Pharmaceuticals in 2021 and commercializes Epidiolex (cannabidiol) for epilepsy—making it the most established commercial-stage cannabinoid therapeutics peer and a benchmark for FDA-approved cannabinoid Rx economics.
• Tilray Brands: Tilray is a large global cannabis operator with a pharmaceutical division producing cannabinoid-based medicines. Comparable in cross-jurisdiction medicinal cannabis commercialization and pharmacy distribution footprint.
• Canopy Growth: Canopy Growth operates Spectrum Therapeutics, a medical cannabis business spanning multiple countries, and pursues cannabinoid-based pharmaceutical R&D—directly comparable to Zelira's Rx and consumer medical cannabis strategy.
• Aurora Cannabis: Aurora Cannabis operates a global medical cannabis platform with pharmacy distribution across multiple jurisdictions. Comparable in medicinal cannabis commercialization and multi-market regulatory strategy.

Direct peers

• Tetra Bio-Pharma: Tetra Bio-Pharma is a cannabinoid-based biopharmaceutical company developing FDA-track Rx products for pain and inflammation. Closely aligned with Zelira's ZTL-103 chronic pain and diabetic nerve pain clinical programs.
• Cardiol Therapeutics: Cardiol Therapeutics develops pharmaceutically manufactured cannabinoid-based therapeutics targeting inflammatory heart disease—a peer with similar biotech development model targeting FDA-approved cannabinoid drug pathways.
• InMed Pharmaceuticals: InMed Pharmaceuticals focuses on cannabinoid-based pharmaceutical development, including rare disease indications. Comparable clinical-stage biopharmaceutical positioning targeting FDA pathways with proprietary cannabinoid formulations.
• Botanix Pharmaceuticals: Botanix Pharmaceuticals develops prescription cannabinoid-based dermatology and antimicrobial products—comparable to Zelira's dermatology/OTC topical cannabinoid franchise and FDA-track dermatology pipeline.

Regional players

• OrganiGram Holdings: OrganiGram is a Canadian licensed producer of medical and recreational cannabis pursuing pharmaceutical-grade cannabinoid products. Comparable in clinically positioned medicinal cannabis development and pharmacy channel distribution.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@ZeliraTherapeutics
• Facebookfacebook.com/7NEWSAustralia
• LinkedInlinkedin.com/company/zelira-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Zelira Therapeutics