Frenelle Pharma
Frenelle Pharma is a clinical-stage biotech portfolio company developing long-acting injectable therapeutics using its proprietary Faros™ PLGA microsphere platform across pain, addiction, and animal health through three wholly-owned subsidiaries.
- Company typePrivate
- Founded-
- HeadquartersPlymouth, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Frenelle Pharma does
Frenelle Pharma is a privately held clinical-stage biotech portfolio company headquartered in Plymouth, Minnesota (Medical Alley), operating under a hub-and-spoke model in which a single proprietary drug delivery platform, Faros™, is deployed across three wholly-owned therapeutic-area subsidiaries. Faros™ is a long-acting injectable (LAI) technology built on PLGA microspheres engineered as uniform, spherical, non-porous particles smaller than red blood cells, which the company claims solves the batch-to-batch variation and burst-release problems of conventional PLGA microspheres. The three subsidiaries are SpineThera (Phase 2 asset SX600, sustained-release dexamethasone for lumbar radicular pain/sciatica), Frenelle PBC (preclinical/IND-enabling asset FRN01, 30-day subcutaneous buprenorphine for opioid use disorder, co-developed with Mayo Clinic and structured as a public benefit corporation), and Anumio (animal health; lead asset ANM02, a 90-day injectable phenylpropanolamine for canine urinary incontinence, targeting FDA Expanded Conditional Approval). The franchise controls at least 7 US patents on the Faros/SpineThera platform, with additional research extending into inhalation and suprachoroidal delivery routes.
The company has invested over ten years perfecting the Faros™ platform, formally launched the consolidated brand at JPM Healthcare Conference in January 2025, and pursues a multi-pronged monetization model: subsidiary ownership and direct-investment opportunities in those subsidiaries, co-development and out-licensing of Faros™ to external partners, and future commercialization of subsidiary-owned products through pharmaceutical distribution, healthcare-provider networks, and (for Anumio) veterinary channels. As of the most recent disclosures, the company is pre-revenue, with the headcount band stated as 1-10 and leadership comprising CEO/Chairman Jeffrey Missling, CFO Mark Payne, CMO Dr. Lee Techner, VP R&D Emily Meyering, plus an Australian Medical Director and four board members. Strategic distribution posture is enterprise-focused: human health products are aimed at hospitals, pain clinics, and addiction treatment facilities, while Anumio targets the companion-animal veterinary market via FDA's Expanded Conditional Approval pathway.
Frenelle Pharma firmographics
Firmographics- Name
- Frenelle Pharma
- Legal name
- Frenelle Pharma
- Website
- https://frenellepharma.com
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Frenelle Pharma is a clinical-stage biotech portfolio company developing long-acting injectable therapeutics using its proprietary Faros™ PLGA microsphere platform across pain, addiction, and animal health through three wholly-owned subsidiaries.
- Ownership category
- akta.pro rank
Frenelle Pharma industry classification
Industry- Product category
- Long-acting injectable drug delivery
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Pain Management & Anesthesiology Pharmaceuticals (HLAIAAAN)
- akta.pro secondary industries
- Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Ophthalmology Pharmaceuticals (HLAIAAAL), Primary Care & General Medicine Pharmaceuticals (HLAIAAAA)
Keywords
Where Frenelle Pharma is headquartered
LocationHeadquarters
- HQ city
- Plymouth
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Frenelle Pharma business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Subsidiary Investment and Ownership: Frenelle Pharma has successfully launched three companies built on its Faros™ technology (SpineThera, Frenelle PBC, Anumio), each focused on a different therapeutic area. The company generates value through ownership in subsidiaries and direct investment opportunities.
- Co-development and Out-licensing: The company pursues co-development and out-licensing opportunities for Faros™ technology with strategic partners, generating revenue through partnership agreements and technology licensing.
- Animal Health Products (Anumio): Anumio is positioned to advance toward proof-of-concept studies and capitalize on the growing companion animal drug market, targeting eventual commercialization of long-acting injectable therapeutics for companion animals.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Frenelle Pharma product offering
Product offeringCore offering
Frenelle Pharma develops the proprietary Faros™ long-acting injectable (LAI) drug delivery technology based on PLGA microspheres that deliver consistent, sustained-release drug profiles from a single injection. Operating a hub-and-spoke model, the company advances therapeutics across three wholly-owned subsidiaries: SpineThera (SX600 for lumbar radicular pain/sciatica), Frenelle PBC (FRN01 buprenorphine for opioid use disorder, in collaboration with Mayo Clinic), and Anumio (ANM02 phenylpropanolamine for canine urinary incontinence).
Product overview
Frenelle Pharma operates as a biotech portfolio company with a hub-and-spoke model, using its proprietary Faros™ long-acting injectable (LAI) drug delivery technology platform to advance therapeutics across multiple therapeutic areas. The company has established three subsidiary companies: SpineThera (human health - sciatica/pain), Frenelle PBC (human health - substance use disorders), and Anumio (animal health - companion animals). The Faros™ platform technology enables sustained drug release through micro-sized, spherical, non-porous PLGA microspheres. Lead products include SX600 (dexamethasone for lumbar radicular pain), FRN01 (buprenorphine for opioid use disorder), and ANM02 (phenylpropanolamine for canine urinary incontinence).
Differentiator
Problem solved
Functional benefit
Brands
- Faros™: Proprietary long-acting injectable (LAI) drug delivery technology featuring micro-sized, spherical, non-porous PLGA microspheres that deliver consistent drug release profiles. The technology enables injections through very small gauge needles and is surfactant and preservative free.
Products and services
- Faros™ Long-Acting Injectable Technology Platform Proprietary PLGA microsphere-based long-acting injectable (LAI) drug delivery platform producing micro-sized, spherical, non-porous, surfactant and preservative-free particles smaller than red blood cells. Enables consistent drug release profiles, injection through very small gauge needles, and months-long sustained release from a single injection. Licensed or co-developed with strategic partners and applied across the company's subsidiaries.
- SX600 (SpineThera) Investigational novel formulation of dexamethasone using Faros™ technology, providing months-long sustained-release epidural injection for patients with lumbar radicular pain (sciatica). Currently in Phase 2 clinical trial; no FDA-approved epidural drug currently exists for this indication.
- FRN01 (Frenelle PBC) Investigational 30-day subcutaneous injection of buprenorphine using Faros™ technology for maintenance therapy in patients with opioid use disorder (OUD). Developed by wholly-owned subsidiary Frenelle PBC in collaboration with Mayo Clinic. Pre-clinical proof of concept has demonstrated favorable PK profiles with low burst release and sustained drug levels over 30 days.
- ANM02 (Anumio) Investigational 90-day injectable phenylpropanolamine (PPA) product for treatment of canine urinary incontinence, developed by wholly-owned animal health subsidiary Anumio using Faros™ technology. Designed for FDA Expanded Conditional Approval pathway to enable rapid commercialization in companion animal therapeutics.
Quantifiable outcome
- Phase 2 trial demonstrated clinically meaningful and durable reduction in lumbar radicular pain from single epidural injection of SX600
- +2 more outcomes
Companies that use Frenelle Pharma
Customer profileSegments3 records
Ideal customer profiles4 records
Frenelle Pharma technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Frenelle Pharma partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Mayo CliniccoreFrenelle PBC has partnered with the Mayo Clinic to leverage Frenelle's Faros™ technology and Mayo Clinic's addiction medicine expertise to create effective and accessible treatment options for patients suffering from substance use disorders. The collaboration focuses on developing long-acting injectables for substance use disorders with a mission to maximize access and utilization.
Scale indicators5 records
Recent moves9 records
Expansion highlights5 records
Frenelle Pharma competitors and assessment
Company assessmentBroad incumbents
- Elanco Animal Health: Elanco is a global animal health leader (including Dechra Pharmaceuticals following acquisition). Comparable to Frenelle's Anumio as an established player in companion animal drug markets the Anumio lead asset (canine urinary incontinence PPA) would enter.
- Zoetis: Zoetis is the largest global animal health pharmaceutical company with a broad portfolio including canine therapeutics. Comparable to Frenelle's Anumio subsidiary as a target market incumbent for companion animal long-acting injectables.
- Halozyme Therapeutics: Halozyme's ENHANZE drug delivery platform enables subcutaneous delivery of large-molecule biologics via recombinant hyaluronidase. Comparable as a broad drug delivery platform with established licensing model across therapeutic areas, though mechanistically distinct from PLGA microspheres.
Emerging players
- Lyndra Therapeutics: Lyndra develops ultra-long-acting oral drug delivery formulations aimed at reducing dosing frequency (e.g., weekly-to-monthly oral dosage forms). Comparable emerging-stage company pursuing long-duration drug delivery, though via a different route than Frenelle's injectables.
Direct peers
- Pacira BioSciences: Pacira's Exparel is a long-acting injectable bupivacaine multivesicular liposome product for postsurgical and interventional pain. Pacira is the most established U.S. LAI pain company and the closest commercial analogue to Frenelle's SpineThera sciatica program.
- Oakwood Labs: Oakwood Labs is a CDMO specializing in PLGA-based long-acting injectable microspheres. It is one of the few competitors working in the same polymer microsphere LAI space as Faros™ and represents the closest technical analogue.
- Heron Therapeutics: Heron markets Zynrelef (long-acting bupivacaine/meloxicam) and has a pipeline of long-acting injectable pain and supportive-care products. Comparable to Frenelle's LAI pain franchise via sustained-release injectable drug delivery for pain indications.
- Camurus: Camurus markets Buvidal (weekly/monthly subcutaneous buprenorphine LAI) and has a FluidCrystal long-acting injectable technology platform applicable across multiple therapeutic areas. Direct comparable to both Frenelle PBC's FRN01 and the Faros™ platform strategy.
- Braeburn: Braeburn commercializes Sublocade, the once-monthly subcutaneous buprenorphine LAI for opioid use disorder. It is the closest direct competitor to Frenelle PBC's FRN01 (30-day subcutaneous buprenorphine).
- Titan Pharmaceuticals: Titan developed Probuphine, a six-month subcutaneous buprenorphine implant for OUD maintenance, using a sustained-release drug delivery approach. Highly comparable to Frenelle PBC's mission of long-acting buprenorphine delivery for OUD.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks5 records
Key highlights6 records
Customer concentration
Frenelle Pharma social profiles
Digital presenceFrenelle Pharma financial estimates
Financial estimateRevenue estimate
Valuation estimate
Frenelle Pharma leadership team
Management profileNumber of profiles
Profiles10 records
Frenelle Pharma subsidiaries and ownership
Company hierarchySubsidiaries3 records
Frenelle Pharma funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Frenelle Pharma M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Frenelle Pharma
What does Frenelle Pharma do?
Frenelle Pharma develops the proprietary Faros™ long-acting injectable (LAI) drug delivery technology based on PLGA microspheres that deliver consistent, sustained-release drug profiles from a single injection. Operating a hub-and-spoke model, the company advances therapeutics across three wholly-owned subsidiaries: SpineThera (SX600 for lumbar radicular pain/sciatica), Frenelle PBC (FRN01 buprenorphine for opioid use disorder, in collaboration with Mayo Clinic), and Anumio (ANM02 phenylpropanolamine for canine urinary incontinence).
Is Frenelle Pharma a public or private company?
Frenelle Pharma is a private company. It is classified as unknown and is currently operating.
When was Frenelle Pharma founded?
Frenelle Pharma was founded in -1. It employs 1 to 10 people.
Where is Frenelle Pharma based?
Frenelle Pharma is headquartered in Plymouth, United States, in the North America region.
How does Frenelle Pharma make money?
Three revenue lines are on record. Subsidiary Investment and Ownership is the primary driver. The others are co-development and Out-licensing and animal Health Products (Anumio).
Who are Frenelle Pharma's main competitors?
Broad incumbents on record are Elanco Animal Health, Zoetis and Halozyme Therapeutics. Lyndra Therapeutics is listed as an emerging player. Direct peers are Pacira BioSciences, Oakwood Labs, Heron Therapeutics, Camurus, Braeburn and Titan Pharmaceuticals.
Does Frenelle Pharma have an API?
No public API is recorded for Frenelle Pharma.
What industry is Frenelle Pharma in?
Frenelle Pharma's product category is Long-acting injectable drug delivery. Its primary akta.pro industry code is HLAIAAAN, Pain Management & Anesthesiology Pharmaceuticals, with a secondary code of HLAIACAC, Neurology & CNS Specialty Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.