Veloxis

What Veloxis does

Veloxis Pharmaceuticals, Inc. is a U.S.-headquartered specialty pharmaceutical company focused on transplant medicine and, following its April 2026 acquisition of Aicuris, on severe infectious diseases in immunocompromised patients. The company operates as a wholly-owned subsidiary of Japan's Asahi Kasei Corporation and runs commercial operations from Cary, North Carolina (with historical roots in Hørsholm, Denmark), alongside clinical development, regulatory affairs, and R&D functions. Veloxis's marketed core product is ENVARSUS XR, a once-daily extended-release tacrolimus tablet for prophylaxis of organ rejection in kidney transplant patients (both de novo and conversion), built on its proprietary MeltDose drug-delivery technology that improves bioavailability and dose consistency versus immediate-release tacrolimus.

The pipeline targets long-standing gaps in transplant immunosuppression and antiviral therapy. Pegrizeprument (VEL-101 / FR104) is a pegylated monoclonal antibody fragment CD28 antagonist licensed from OSE Immunotherapeutics in April 2021, currently in Phase 2 for kidney transplant (FDA Fast Track Designation since 2022) and granted FDA Orphan Drug Designation for liver (January 2026) and heart (April 2026) transplant indications. The April 2026 acquisition of Aicuris Anti-infective Cures AG for €780M (~$920M) added three antiviral assets: Prevymis / letermovir (marketed by MSD, generating a projected $100M–$200M annual royalty stream), pritelivir (under FDA Priority Review with a Q4 2026 PDUFA target for immunocompromised refractory HSV, projected peak revenue >$400M in the mid-to-late 2030s), and AIC468 (Phase 2 antisense oligonucleotide for BK virus in kidney transplant recipients, with a market opportunity estimated at over $1B).

Veloxis operates an enterprise field-sales model in the U.S., deploying transplant account managers who detail physicians and transplant centers directly, complemented by community engagement via transplant professional societies (AST, ASTS, ITNS, NATCO), investigator-initiated studies, scientific congress activity (ATC, WTC, ESOT), and patient-focused programs. Revenue is generated through (i) U.S. product sales of ENVARSUS XR to transplant centers, hospitals, and specialty pharmacies; (ii) royalty income from Prevymis via the MSD license; and (iii) projected future revenues from pritelivir, AIC468, and pegrizeprument, with international reach pursued through licensing and distribution partnerships. The company benefits from Asahi Kasei's "One AK Pharma" integrated platform spanning Japan, the U.S., and Europe, and from parent capital deployed for acquisitions and sustained R&D investment.

Name

Veloxis

Legal name

Veloxis Pharmaceuticals, Inc.

Website

https://veloxis.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

11–50 employees

Short description

Veloxis Pharmaceuticals is a U.S. specialty pharmaceutical subsidiary of Asahi Kasei Corporation that commercializes ENVARSUS XR for kidney transplant immunosuppression and develops a transplant and antiviral pipeline (pegrizeprument, pritelivir, AIC468), expanded by the 2026 Aicuris acquisition.

Ownership category

akta.pro rank

Product category

Transplant Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

akta.pro secondary industries

Specialty Care Pharmaceuticals (HLAIAAAB), Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH), Immunology & Inflammation Pharmaceuticals (HLAIAAAD)

Keywords

• Transplant immunosuppression
• Extended-release tacrolimus
• Kidney transplant medicine
• Antiviral therapeutics
• Specialty pharmaceuticals

Headquarters

HQ city

Hørsholm

HQ country

Denmark

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical product sales: Veloxis generates revenue through the direct commercialization of ENVARSUS XR (tacrolimus extended-release tablets) in the U.S. market, sold to transplant centers, hospitals, and dispensed through pharmacies to kidney transplant patients.
2. Licensed product royalties (Prevymis): Through the Aicuris acquisition, Veloxis manages a consistent royalty stream from Prevymis (letermovir), licensed to MSD, generating estimated annual royalty revenue of $100 million to $200 million depending on sales levels.
3. Pipeline drug development and commercialization: Veloxis is advancing a pipeline of investigational drugs (pegrizeprument, pritelivir, AIC468) toward regulatory approval and commercialization, with pritelivir projected to achieve peak revenue exceeding $400 million in the mid-to-late 2030s and AIC468 targeting a market opportunity over $1 billion.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Veloxis Pharmaceuticals is a specialty pharmaceutical company that develops, manufactures, and commercializes therapeutics for organ transplant recipients and other immunocompromised patients. Its marketed product ENVARSUS XR is a once-daily extended-release tacrolimus tablet built on proprietary MeltDose technology, indicated for prophylaxis of kidney transplant rejection. The company is advancing a pipeline of novel immunosuppressants (pegrizeprument/VEL-101) and antivirals (pritelivir, AIC468), and earns royalty revenue from Prevymis through the Aicuris acquisition.

Product overview

Veloxis is a fully integrated specialty pharmaceutical company focused on transplant medicine and serious infectious diseases. The company's product portfolio includes ENVARSUS XR (tacrolimus extended-release tablets), its marketed core product for kidney transplant immunosuppression using proprietary MeltDose technology. The pipeline features pegrizeprument (VEL-101), a Phase 2 CD28 costimulation blocker licensed from OSE Immunotherapeutics for solid organ transplant rejection prevention. Following the April 2026 acquisition of Aicuris Anti-infective Cures AG for €780 million, the portfolio expanded to include antiviral assets: pritelivir (Filed, targeting immunocompromised refractory HSV), AIC468 (Phase 2, for BK virus in kidney transplant recipients), and royalties from marketed drug Prevymis. Together these assets address transplant immunology, infectious diseases in immunocompromised patients, and serious viral complications.

Differentiator

Problem solved

Functional benefit

Products and services

• ENVARSUS XR (tacrolimus extended-release tablets) A once-daily, extended-release tacrolimus formulation built on Veloxis's proprietary MeltDose technology. Indicated for prophylaxis of organ rejection in de novo kidney transplant patients and in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Marketed in the U.S. through Veloxis's transplant commercial sales force and dispensed via retail and specialty pharmacies.
• Pegrizeprument (VEL-101) Pegylated monoclonal antibody fragment that selectively binds and blocks CD28-mediated effector-T cell costimulation while preserving CTLA-4 immunosuppressive function, providing a dual mechanism of action for prevention of acute rejection in solid organ transplant recipients. Licensed from OSE Immunotherapeutics in April 2021 with worldwide rights for all transplant indications. In Phase 2 development for kidney transplant rejection prophylaxis; FDA Fast Track Designation (2022) and Orphan Drug Designations for liver (January 2026) and heart (April 2026) transplant indications.
• AIC468 Antisense oligonucleotide therapeutic candidate designed to treat reactivation of BK virus (BKV) in kidney transplant recipients by disrupting BKV replication directly within infected cells through targeted BKV transcript engagement. Phase 2 clinical stage, targeting an area of increasing clinical importance with a potential market opportunity estimated at over $1 billion. Acquired through the April 2026 Aicuris Anti-infective Cures AG acquisition.
• Pritelivir Thiazolylamide-based antiviral compound designed to inhibit herpes simplex virus (HSV) replication by targeting the viral helicase-primase complex. Active against HSV-1, HSV-2, and treatment-refractory/aciclovir-resistant HSV strains. Filed with FDA for immunocompromised refractory HSV under Priority Review with PDUFA target date Q4 2026. Acquired through the Aicuris acquisition.
• Prevymis (letermovir) Royalty Stream Royalty stream from FDA-approved antiviral Prevymis (letermovir) licensed to MSD, acquired through the April 2026 acquisition of Aicuris Anti-infective Cures AG. Generates estimated annual royalty revenue of $100 million to $200 million depending on sales levels, managed by Veloxis as part of Asahi Kasei's "One AK Pharma" platform.

Quantifiable outcome

• Pegrizeprument monotherapy significantly increased rejection-free survival (P=0.0128) vs. no immunosuppression in NHP kidney transplant model; combination with standard of care showed comparable survival (P=0.6714) to tacrolimus-based immunosuppression with potentially improved safety profile
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• Aicuris Anti-infective Cures AGcoreStrategic or Co-development Partner · 20 April 2026Asahi Kasei, through its U.S. subsidiary Veloxis Pharmaceuticals, completed acquisition of German biopharma Aicuris for approximately €780 million (~$920 million). Aicuris brings three antiviral assets: Prevymis (marketed, licensed to MSD), pritelivir (Phase 3, FDA Priority Review, PDUFA Q4 2026), and AIC468 (Phase 2-ready for BK virus). Aicuris projected to generate $500 million in revenue by 2030.
• LyfebulbminorGTM or Marketing Partner · 17 October 2022Veloxis partnered with Lyfebulb (patient empowerment platform) for the annual 'Lyfebulb–Veloxis Innovation Challenge in Organ Transplantation.' The challenge awards $25,000 (Innovation Award, for-profit) and $15,000 (Impact Award, not-for-profit) to entrepreneurs developing solutions for transplant patients. Veloxis may consider partnerships or investments with finalists.
• Xenikos B.V. — T-Guard Phase 3 PartnershipminorStrategic or Co-development Partner · 28 June 2022Veloxis partnered with Xenikos to support the global Phase 3 trial of T-Guard versus ruxolitinib for Grade III/IV steroid-refractory acute GVHD following allogeneic hematopoietic stem cell transplant. The 246-patient trial conducted at 75 transplant centers across the U.S. and Europe in collaboration with the BMT CTN.
• AlchemedicineminorStrategic or Co-development Partner · 1 January 2022Asahi Kasei Pharma and Alchemedicine entered an exclusive license agreement in 2022, with Asahi Kasei acquiring worldwide development and commercialization rights to AK1960 (ETA receptor antagonist) derived from Alchemedicine's HiSAP platform. Veloxis Pharmaceuticals and Calliditas Therapeutics will support continued development of AK1960 toward global markets.
• OSE ImmunotherapeuticscoreStrategic or Co-development Partner · 26 April 2021OSE Immunotherapeutics licensed pegrizeprument (VEL-101, formerly FR104) to Veloxis in April 2021. Veloxis obtained worldwide rights to develop, manufacture, and commercialize pegrizeprument for all transplant indications. OSE Immunotherapeutics may receive up to €315 million in potential milestones including €7 million upfront, plus tiered royalties on sales.
• Critical Path Institute — Transplant Therapeutics Consortium (TTC)minorStrategic or Co-development Partner · 18 June 2020Veloxis has been a member of the Critical Path Institute's Transplant Therapeutics Consortium since 2017. The TTC, co-founded by AST and ASTS, achieved EMA Draft Qualification Opinion for the iBox Scoring System — the first qualified endpoint for any transplant indication — enabling accelerated regulatory pathways for novel immunosuppressants.
• American Society of Transplantation (AST)minorGTM or Marketing PartnerVeloxis partners with AST, a major transplant professional society, to advance transplant education, research, and patient care. AST is a key stakeholder organization in the transplant community.
• American Society of Transplant Surgeons (ASTS)minorGTM or Marketing PartnerVeloxis partners with ASTS, the professional society representing transplant surgeons and physicians, as part of its community engagement strategy in transplant medicine.
• International Transplant Nurses Society (ITNS)minorGTM or Marketing PartnerVeloxis partners with ITNS to support transplant nursing education and professional development, engaging with transplant nursing professionals who play a key role in patient care and medication management.
• Donate Life North CarolinaminorGTM or Marketing PartnerVeloxis is premier sponsor of the annual Gift of Life Gala benefiting Donate Life NC, supporting organ donation awareness and registry enrollment efforts across North Carolina.
• Asahi Kasei Corporation — Parent CompanycoreStrategic or Co-development PartnerVeloxis is a wholly owned U.S. subsidiary of Asahi Kasei Corporation, a diversified Japanese conglomerate with 50,000+ employees. Asahi Kasei provides strategic direction, capital (including the €780M Aicuris acquisition), and global pharmaceutical platform integration under its 'One AK Pharma' operating model across Japan, U.S., and Europe.

Scale indicators8 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• Astellas Pharma: Astellas markets Prograf (tacrolimus), the leading branded IR-tacrolimus and ENVARSUS XR's primary direct competitor in kidney transplant immunosuppression. Both companies compete for transplant center formulary inclusion and physician adoption.
• Calliditas Therapeutics: Calliditas is a Swedish specialty pharma partnered with Veloxis (on AK1960) and focused on rare disease therapeutics with overlap in transplant-adjacent indications. Similar specialty-pharma commercial model and orphan drug strategy.

Broad incumbents

• Bristol-Myers Squibb: BMS markets Nulojix (belatacept), a CTLA-4-Ig immunosuppressant for kidney transplant rejection prophylaxis, the most direct mechanistic competitor to pegrizeprument's CD28-blockade approach. BMS has broad pharma scale and deep transplant commercial reach.
• Novartis: Novartis markets Neoral/Sandimmune (cyclosporine) and other transplant immunosuppressants and has broad specialty pharma operations. As a global pharma incumbent, it competes in adjacent transplant immunology indications and has the scale to enter niche spaces.
• AbbVie: AbbVie markets Humira and other immunology/immunosuppressant products and has signaled continued investment in immunology R&D. Competes in adjacent autoimmune and transplant-adjacent indications and could enter the transplant space via M&A.

Emerging players

• OSE Immunotherapeutics: OSE Immunotherapeutics is the originator/licensor of pegrizeprument (FR104/VEL-101) and operates in the same immunology/transplant space. Direct counterparty with a shared pipeline asset and overlapping therapeutic area expertise.
• CareDx: CareDx is a transplant-focused diagnostics company (AlloSure, AlloMap) that serves the same transplant center customers as Veloxis. Different product category (diagnostics vs. therapeutics) but directly comparable customer base and commercial motion.
• Hansoh Pharmaceutical: Hansoh is a Chinese specialty pharma with growing transplant and immunology pipeline investments. Represents an emerging global competitor in transplant therapeutics with the manufacturing scale to pressure pricing in international markets.
• Cidara Therapeutics: Cidara is a clinical-stage antiviral biotech developing novel immunotherapies and antivirals, partially overlapping with the Veloxis/Aicuris antiviral pipeline (HSV, BK virus). Similar stage and therapeutic focus with comparable platform technology positioning.

Others

• Merck & Co. (MSD): MSD is the marketing partner for Prevymis (letermovir) and pays royalties to Aicuris/Veloxis. As a key counterparty and leading antiviral pharma, MSD represents both a commercial partner and a potential competitive threat in adjacent transplant antiviral indications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/veloxis-pharmaceuticals
• Xx.com/VeloxisPharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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

M&A1 record

Investments1 record

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

Frequently asked questions about Veloxis