Lupus Therapeutics

What Lupus Therapeutics does

Lupus Therapeutics is a 501(c)(3) nonprofit clinical research organization and the clinical affiliate of the Lupus Research Alliance, founded in 2017 to advance new therapies for lupus and lupus nephritis. The organization describes itself as the first and only lupus organization to conduct its own clinical trials, operating primarily through its proprietary Lupus Clinical Investigators Network (LuCIN), which spans 50+ premier academic medical centers across North America and 200+ clinician-researchers. LuCIN provides site identification, contract and budget negotiation (200+ executed negotiations averaging ~4 months each), and site liaison services to biopharma sponsors.

Its core technology is the LuCIN investigator network itself, complemented by the LuCIN Centers Portal (an exclusive resource platform for member investigators), the Healthcare Provider Directory connecting patients with lupus specialists, and the PALS peer-to-peer education program that trains patient advocates to drive diverse clinical trial enrollment. Additional programs include Project CHANGE (a community-based health equity initiative piloted at Emory, Vanderbilt, and UPenn), the IDEAL Initiative funding diet/microbiome studies up to $500K per study, and an Immune Resetting Therapies Resource Center covering CAR-T and cell therapy modalities.

The business model is nonprofit professional services: revenue flows from contracted clinical research and advisory services to biopharmaceutical sponsors, supplemented by NIH and FDA grants (e.g., a $500,000 NIH/FDA Innovation Award in 2022) and parent Lupus Research Alliance funding of administrative costs. Sponsors include AbbVie, Biogen, Bristol Myers Squibb, Genentech, Novartis, UCB, Janssen, Cabaletta Bio, Nkarta, Artiva, Immunovant, Zenas BioPharma, Autolus, Cullinan Therapeutics, GSK, and PPD. Customers are exclusively enterprise biopharma; the patient and investigator communities are participants rather than paying customers.

Name

Lupus Therapeutics

Legal name

Lupus Therapeutics

Website

https://lupustherapeutics.org

Company type

Private

Founded year

2017

Operating status

Operating

Short description

Lupus Therapeutics is the 501(c)(3) clinical affiliate of the Lupus Research Alliance, operating the LuCIN network of 50+ academic medical centers and 200+ clinician-researchers to run lupus clinical trials for biopharmaceutical sponsors and advance patient engagement and health equity programs.

Ownership category

akta.pro rank

Product category

Clinical Research Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Site Network Operators & SMOs (HLAGACAA)

akta.pro secondary industries

Clinical Trial Site Operations & Study Coordination (HLAGACAE), Cell Therapy Clinical Services & Treatment Centers (apheresis, administration, monitoring) (HLAAABAJ)

Keywords

• Clinical research services
• Lupus clinical trials
• Clinical investigator network
• Biopharmaceutical partnerships
• Patient engagement programs

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Lupus Therapeutics operates as a nonprofit clinical affiliate of the Lupus Research Alliance, providing clinical research services to biopharmaceutical companies through its LuCIN network. Revenue appears to come from service contracts with pharmaceutical partners for clinical trial facilitation.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Lupus Therapeutics operates a lupus-focused clinical research organization that runs Phase 1 through Phase 3 clinical trials for biopharmaceutical and biotechnology sponsors through its proprietary Lupus Clinical Investigators Network (LuCIN) of 50+ premier academic medical research centers and 200+ clinician-researchers. Core deliverables include site identification and feasibility, contract and budget negotiation, site liaison, and medical and scientific advisory consulting that connect sponsors with leading lupus key opinion leaders across North America.

Product overview

Lupus Therapeutics is the clinical affiliate of the Lupus Research Alliance, operating as a clinical research organization focused on advancing lupus treatments. The core offering is the Lupus Clinical Investigators Network (LuCIN), a proprietary network of 50+ premier academic medical research centers across North America with 200+ clinician-researchers. This network is complemented by patient engagement programs including the PALS peer-to-peer education program and Project CHANGE community-based health equity initiative. Additional services include clinical research services (site identification, contract negotiation, site liaison), advisory and consulting services, a Healthcare Provider Directory, and the IDEAL Initiative for diet and microbiome research. The organization facilitates partnerships with biopharmaceutical companies including AbbVie, Biogen, BMS, Genentech, Novartis, UCB, and others to conduct clinical trials across various phases.

Differentiator

Problem solved

Functional benefit

Brands

• LuCIN (Lupus Clinical Investigators Network): A network of premier clinical research centers in North America managed by Lupus Therapeutics to help progress clinical trials forward faster for sponsors/investigators
• PALS (Patient Advocates for Lupus Studies)
• Project CHANGE
• IDEAL Initiative (Investigate Dietary Approaches for Lupus)
• Healthcare Provider Directory

Products and services

• Lupus Clinical Investigators Network (LuCIN) Proprietary network of 50+ premier clinical research centers and 200+ experienced clinician-researchers across North America that conducts lupus clinical trials for biopharmaceutical sponsors.
• PALS (Patient Advocates for Lupus Studies) Peer-to-peer clinical trial education program that connects individuals living with lupus with trained patient advocates who provide early education about clinical trials and trial-specific support to increase diverse representation in lupus research.
• Project CHANGE Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities, a community-driven approach that addresses systemic challenges contributing to underrepresentation of people of color in lupus clinical trials through local Lupus Research Collaboratives.
• Healthcare Provider Directory Proprietary directory connecting patients with healthcare providers specializing in lupus care and clinical trials throughout North America.
• IDEAL Initiative (Investigate Dietary Approaches for Lupus) Funding mechanism supporting pilot clinical studies that assess the impact of diet intervention on lupus management and disease course, offering grants up to $500,000 per study over two years.
• Clinical Research Services Full suite of clinical research services for biopharmaceutical sponsors including site identification and feasibility, contract and budget negotiation (more than 200 unique negotiations successfully conducted, averaging approximately four-month timelines), and site liaison services to streamline lupus clinical trial conduct.
• Advisory & Consulting Services Medical and scientific consulting services connecting biopharmaceutical companies with LuCIN key opinion leaders for synergistic collaboration on lupus clinical research development, including protocol review, trial design, regulatory planning, and patient-reported outcome development.
• Immune Resetting Therapies Resource Center Resource center providing information about immune resetting therapies and cell therapy approaches for lupus treatment, including CAR T cell therapies and other innovative treatment modalities.

Quantifiable outcome

• More than 200 unique contract and budget negotiations conducted successfully with LuCIN sites
• +3 more outcomes

Named customers10 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

18 partnerships are on record, tiered minor and core.

• Artiva BiotherapeuticsminorStrategic or Co-development Partner · 1 March 2024Collaboration to support evaluation of non-genetically modified cell-based therapy for lupus nephritis. Allogeneic NK cell therapy research.
• NkartaminorStrategic or Co-development Partner · 1 October 2023Partnership to support evaluation of Natural Killer (NK) cell therapy in lupus nephritis. NKX019 Phase 1 allogeneic CAR NK cell therapy trial.
• KDH Research and CommunicationminorImplementation/ SI/ Consulting Partner · 1 June 2023Research and evaluation partner for Project CHANGE initiative, tracking outcomes, challenges, and successes of Lupus Research Collaboratives.
• Decision Information Resources, Inc.minorImplementation/ SI/ Consulting Partner · 1 June 2023Evaluation partner for Project CHANGE initiative.
• Cabaletta BiominorStrategic or Co-development Partner · 1 May 2023FDA Fast Track designation for CABA-201 CAR T cell therapy for SLE and lupus nephritis. Phase 1/2 RESET-SLE and RESET-Myositis trials.
• AbbVie Inc.coreStrategic or Co-development Partner · 1 March 2023March 2023 partnership began a Phase 3 clinical program evaluating upadacitinib for systemic lupus erythematosus. Also includes AbbVie SELECT-SLE Phase 3 trial at up to 20 LuCIN sites in U.S. and Canada.
• PPD (Pharmaceutical Product Development)minorStrategic or Co-development Partner · 1 September 2020Collaboration to accelerate lupus clinical research through PPD's CRO services.
• BiogencoreStrategic or Co-development PartnerMultiple collaborations including TOPAZ-1, TOPAZ-2 Phase 2 trials, AMETHYST Phase 2/3 for litifilimab in cutaneous lupus erythematosus, and dapirolizumab pegol PHOENYCS GO/FLY trials with UCB.
• Bristol Myers SquibbcoreStrategic or Co-development PartnerMultiple SLE and lupus nephritis trials including Breakfree-SLE Phase 2, POETYK-1 and POETYK-2 SLE trials, historical Paisley SLE and LN trials, and CAR-T cell therapy research.
• GenentechcoreStrategic or Co-development PartnerGA45767 Phase 1 SLE study and Gazyva (obinutuzumab) trials for lupus nephritis and SLE including positive Phase 3 results published in NEJM.
• NovartiscoreStrategic or Co-development PartnerThree Phase 3 ianalumab trials: SIRIUS-LN for lupus nephritis, SIRIUS SLE 1 and SIRIUS SLE 2 for systemic lupus erythematosus, plus CYTB323 Phase 2 trial.
• UCBcoreStrategic or Co-development PartnerPhoenycs Fly and PHOENYCS GO Phase 3 trials for dapirolizumab pegol in moderate-to-severe systemic lupus erythematosus. PHOENYCS GO showed 50% less severe disease flares vs standard of care.
• Janssen PharmaceuticalscoreStrategic or Co-development PartnerGARDENIA-SLE trial at up to 20 LuCIN sites in U.S. Historical collaboration included LOTUS trial at 27 LuCIN sites and Orchid study.
• ImmunovantminorStrategic or Co-development PartnerIMVT-1402-2701 Phase 2 trial for cutaneous lupus erythematosus at 3-4 LuCIN sites in U.S.
• Zenas BioPharmaminorStrategic or Co-development PartnerSunStone trial at up to 16 LuCIN sites in U.S. and Canada.
• AutolusminorStrategic or Co-development PartnerAUTO1-SL2 autologous obecabtagene autoleucel CAR T therapy clinical services.
• Cullinan TherapeuticsminorStrategic or Co-development PartnerCLN-978 CD19xCD3 bispecific T cell engager Phase 1b SLE trial.
• GlaxoSmithKlineminorStrategic or Co-development PartnerGSK4527363 monoclonal antibody and belimumab combination Phase 1b SLE trial.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• ICON plc: Global CRO competing for lupus and other autoimmune clinical trials. Operates dedicated site networks and therapeutic-area specialists with broader multi-TA coverage than LuCIN.
• Labcorp Drug Development (formerly Covance): Full-service CRO with central lab and clinical development services that compete for lupus clinical trials. Operates a global site network and runs autoimmune therapeutic-area programs.
• Medpace: Mid-to-large CRO with therapeutic-area specialization and embedded site relationships, often competing for autoimmune indications including lupus.
• IQVIA: Largest global full-service CRO and clinical research site operator. Competes with LuCIN for lupus trials through its dedicated therapeutic-area teams and site network, though with far broader multi-TA scope.
• PPD (Thermo Fisher Scientific): Full-service CRO that Lupus Therapeutics explicitly partnered with to accelerate lupus research. Direct competitor for sponsor-funded lupus trial execution work.

Direct peers

• Velocity Clinical Research: Multi-therapeutic integrated site network and SMO offering site management, patient recruitment, and trial conduct services — directly overlapping with LuCIN's site network operator role.
• CenExel: Multi-site clinical research organization with embedded Phase 1 units and therapeutic-area expertise across immunology and autoimmune indications, comparable to LuCIN's specialty SMO positioning.
• Elligo Health Research: Technology-enabled SMO leveraging EHR-based site networks for clinical trial execution, directly comparable to LuCIN's model of activating academic and community research sites for sponsor trials.
• Flourish Research: Integrated clinical research site organization with multi-TA therapeutic coverage and site management services, operating as a direct SMO competitor with multi-specialty capacity.

Others

• Lupus Research Alliance (parent): Parent foundation of Lupus Therapeutics funding all administrative and operational costs. Indirect ecosystem participant that defines mission, governance, and capital availability rather than competing for clinical trial execution work.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/LupusResearch
• Facebookfacebook.com/LupusTherapeutics
• LinkedInlinkedin.com/company/79096/admin/feed/posts
• Instagraminstagram.com/lupusresearchalliance

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 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 Lupus Therapeutics