What Irvine Labs does

Irvine Labs, Inc. is a privately-held, founder-owned pharmaceutical research and contract manufacturing organization headquartered at 7305 Murdy Circle, Huntington Beach, California. Founded in 1997 by Shaun Land and Wendy Hawkins (with James Land as CFO), the company operates as a closely-held California corporation that has never raised institutional capital and reports no parent or holding structure. Since 2013 the founders have steered the business through a Pharmaceutical Research Division focused on natural, botanical-derived therapeutics as alternatives to conventional synthetic pharmaceuticals, targeting pain management, insomnia, atopic dermatitis, opioid use disorder, anxiety, and psychiatric and mood disorders across both human and companion-animal indications.

The company's core technology is a botanical drug research and development platform built around naturally occurring active pharmaceutical ingredients, underpinned by DEA Bulk Drug Manufacturer, Importer, and Exporter registration (including Schedule 1 authority over marijuana and THC), cGMP-compliant manufacturing for human and veterinary end products, GAP-certified botanical cultivation with 12+ years of experience, and proprietary extraction and manufacturing processes. The human pipeline includes insomnia therapeutics in Phase II trials, plus daytime/nighttime pain, topical pain, atopic dermatitis (eczema), and opioid abuse disorder candidates advancing through the FDA approval process. The veterinary pipeline covers canine osteoarthritis, canine anxiety, canine atopic dermatitis, and feline anxiety, each in pivotal studies with the FDA Center for Veterinary Medicine.

Irvine Labs runs a dual business model: a contract development and manufacturing organization (CDMO) function offering DEA-registered bulk manufacturing and supply of botanical medicines and scheduled APIs to pharmaceutical companies, universities, and medical researchers worldwide via direct B2B enterprise sales, alongside a long-cycle proprietary drug development pipeline targeting future FDA-approved commercial products. Revenue streams are characterized as professional services (contract manufacturing) and licensing/royalty-like arrangements (drug and supplement supply), with no publicly disclosed pricing. Named distribution partners include Red Light Holland (psilocybin R&D with multiple Netherlands-to-US 5kg shipments under DEA permits in 2025) and Arizona State University (psychedelic research). The company states it is 'considering investor options,' indicating the first move toward external capital in its history.

Name

Irvine Labs

Legal name

Irvine Labs, Inc.

Website

https://irvinelabs.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

1–10 employees

Short description

Irvine Labs, Inc. is a privately-held, DEA-registered pharmaceutical company in Huntington Beach, California that develops botanical-derived drug candidates for pain, insomnia, dermatitis, opioid use disorder, and companion-animal conditions, and provides contract manufacturing and scheduled API supply to pharmaceutical researchers worldwide.

Ownership category

akta.pro rank

Headquarters

HQ city

Huntington Beach

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Infrastructure

Revenue model

1. Contract Manufacturing Services: Pharmaceutical contract development and manufacturing services providing specialty pharmaceutical solutions with botanical medicines and Schedule 1 active pharmaceutical ingredients for pharmaceutical companies and researchers
2. Drug and Supplement Supply: Supply of DEA scheduled drugs and non-scheduled ingredients to medical researchers and developers for clinical trials and commercial development worldwide

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Irvine Labs is a pharmaceutical research, development, and manufacturing company that develops botanical-based drug candidates for human and veterinary use. The company operates a pipeline of FDA Phase II-stage therapeutics targeting insomnia, pain, atopic dermatitis, and opioid use disorder in humans, and osteoarthritis, anxiety, and atopic dermatitis in companion animals. It also provides DEA-registered, cGMP-compliant contract manufacturing services for botanical medicines and Schedule 1 active pharmaceutical ingredients to pharmaceutical companies, universities, and researchers globally.

Product overview

Irvine Labs is a pharmaceutical research and development company established in 1997, specializing in botanical-based therapeutics. The company operates as both a drug development pipeline and a contract manufacturing organization (CMO). Their human drug pipeline includes therapeutics for Insomnia, Pain Management (daytime, nighttime, and topical formulations), Atopic Dermatitis, and Opioid Abuse Disorder—all progressing through FDA Phase II approval process. Their veterinary pipeline includes therapeutics for Canine Osteoarthritis, Canine Anxiety, Canine Atopic Dermatitis, and Feline Anxiety, working with FDA Center for Veterinary Medicine. As a DEA Bulk Manufacturer, the company also offers contract manufacturing services for botanical medicines and Schedule 1 active pharmaceutical ingredients, serving researchers and commercial developers worldwide.

Differentiator

Problem solved

Functional benefit

Products and services

• Insomnia Therapeutic Natural botanical therapeutic for acute and chronic insomnia that addresses time to sleep, sleep interruptions, and total sleep time; currently in Phase II trial process for FDA approval.
• Pain Management Therapeutics Botanical daytime pain management, nighttime pain management, and topical/localized pain management therapeutics designed to eliminate need for opioids and synthetic pain relievers; currently undergoing FDA approval process.
• Topical Pain Balm Natural topical pain balm for chronic back pain, chronic osteoarthritis, gout, sprains, strains, neuropathic pain, muscle aches, and inflamed tendons; in pipeline for FDA IND submission.
• Atopic Dermatitis (Eczema) Therapeutic Botanical therapeutic for atopic dermatitis shown to be safe, effective, and fast-acting in field studies; proceeding with Phase II studies.
• Opioid Abuse Disorder Therapeutics Daytime, nighttime, and topical pain management therapeutics designed to eliminate need for opioids and treat opioid abuse with safe, effective alternative protocols.
• Canine Osteoarthritis Therapeutic Natural therapeutic for dogs with osteoarthritis shown to be safe and effective in field studies; in pivotal studies with FDA Center for Veterinary Medicine for approval.
• Canine Anxiety Therapeutic Botanical medication for dogs with anxiety shown to be very safe and effective in field studies; in pivotal studies with FDA Center for Veterinary Medicine.
• Canine Atopic Dermatitis Topical Therapeutic Natural topical therapeutic for atopic dermatitis in dogs shown to be safe and effective in field studies; in pivotal studies with FDA Center for Veterinary Medicine.
• Feline Anxiety Therapeutic Natural therapeutic for cats with anxiety shown to be very safe and effective in field studies; proceeding through FDA Center for Veterinary Medicine for approval as prescription drug.
• Contract Pharmaceutical Manufacturing Services DEA-registered bulk manufacturer offering contract product development and manufacturing for botanical medicines and DEA scheduled active pharmaceutical ingredients including oral solutions, capsules, softgels, topicals, and suppositories.

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Red Light HollandcoreStrategic or Co-development Partner · 3 March 2026Red Light Holland and Irvine Labs have an established psilocybin R&D partnership. Irvine Labs serves as Red Light Holland's FDA-compliant, DEA-registered partner for psilocybin research. Red Light Holland has shipped multiple 5kg batches of natural psilocybin from the Netherlands to Irvine Labs in California under DEA import permits to support medical-grade applications and therapeutic research.
• Arizona State UniversitycoreStrategic or Co-development Partner · 3 March 2026Irvine Labs has expanded its psilocybin R&D partnerships to include Arizona State University, supporting psychedelic sector research and development activities alongside the partnership with Red Light Holland.

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• ATAI Life Sciences: Clinical-stage biopharmaceutical company developing psychedelic and non-psychedelic therapies for mental health. Comparable in both psychedelic therapeutics focus and CNS/pain pipeline overlap with Irvine Labs.
• Compass Pathways: Clinical-stage psilocybin therapy developer for treatment-resistant depression. Directly comparable to Irvine Labs' psilocybin R&D efforts with Red Light Holland and ASU, and operates in the same medical psychedelic therapeutic category.
• GW Pharmaceuticals (Jazz Pharmaceuticals): Pioneer in botanical cannabinoid-derived pharmaceuticals (Sativex, Epidiolex). Most directly comparable peer given its focus on FDA-approved plant-based drugs for CNS indications, mirroring Irvine Labs' botanical CNS pipeline.
• MindMed: Psychedelic medicine biotech developing psilocybin, LSD, and MDMA-based therapies for CNS conditions. Comparable to Irvine Labs' psychedelic R&D franchise and shares overlap in pain, anxiety, and psychiatric disorder indications.

Broad incumbents

• Canopy Growth: Major cannabis producer with pharmaceutical and consumer health divisions. A broad incumbent in the cannabis-derived therapeutic category, comparable to Irvine Labs on botanical raw material production and cannabinoid drug development.
• Tilray Brands: Large publicly-traded cannabis and pharmaceutical company with FDA-aligned manufacturing and global distribution. A broader incumbent that operates in the botanical pharmaceutical space and overlaps with Irvine Labs' cannabis/THC and contract manufacturing activities.

Regional players

• Clever Leaves: Vertically integrated cannabis and botanical API manufacturer with GMP-certified cultivation and extraction operations. Comparable to Irvine Labs on GAP-equivalent cultivation, extraction, and bulk botanical API supply.

Emerging players

• Cure Pharmaceutical: Specialty pharmaceutical company using novel drug delivery platforms including botanical-derived actives. Comparable on botanical pharmaceutical manufacturing for human therapeutics and complex dosage form development.
• Zynerba Pharmaceuticals: Clinical-stage specialty pharmaceutical company developing transdermal cannabinoid therapies for CNS conditions including Fragile X syndrome and epilepsy. Comparable to Irvine Labs' topical/transdermal botanical pain pipeline and CNS focus.
• Emerald Health Pharmaceuticals: Clinical-stage botanical-derived drug developer for CNS and autoimmune diseases. Comparable in its use of plant-based compounds for novel drug development targeting multiple sclerosis and CNS conditions similar to Irvine Labs' pipeline.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/irvinelabs

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Irvine Labs