What Pathalys Pharma does

Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company founded in March 2022 and headquartered in Research Triangle Park, North Carolina. The company is focused on developing therapeutics that improve the management of late-stage chronic kidney disease (CKD), with a primary emphasis on secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis for end-stage kidney disease. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group, with Neal Fowler (former CEO of Liquidia Technologies) serving as CEO and BT Slingsby (Managing Partner of Catalys Pacific) as Executive Chairman.

The company's core product is upacicalcet, a novel intravenous small molecule calcimimetic in-licensed from EA Pharma (a subsidiary of Eisai) for worldwide development and commercialization rights outside of Japan and Asia. Upacicalcet activates the calcium-sensing receptor (CaSR) at the highest calcium set point among calcimimetics tested, and is administered as a bolus IV injection at the end of hemodialysis sessions via a pre-filled syringe. It is currently being evaluated in the PATH Phase 3 program, consisting of two identical randomized, double-blind, placebo-controlled trials of approximately 375 patients each (2:1 randomization) with a primary endpoint of ≥30% reduction in intact parathyroid hormone (iPTH). The drug was approved in Japan in 2021 under the brand name UPASITA, with Phase 3 data demonstrating 80.6% of patients achieving ≥30% iPTH reduction, 67% achieving mean iPTH 60-240 pg/mL, and lower adverse event rates (1.9% upper GI AEs vs 6.0% placebo; 1.9% hypocalcemia) versus the Japanese comparator.

Pathalys is pre-revenue and does not yet market any approved products. Its forward business model is direct commercialization of upacicalcet to dialysis providers and nephrology healthcare providers upon FDA approval, leveraging clinical trial relationships with major dialysis operators (notably DaVita, a co-founder). The company retains manufacturing, regulatory, and primary commercialization responsibilities while contracting operational execution of its Phase 3 program to Launch Therapeutics. Cumulative financing raised since founding is approximately $266 million across a 2022 seed, a January 2023 $150 million financing led by Abingworth (part of Carlyle) with OrbiMed, and an August 2024 oversubscribed $105 million Series B led by TCGX with JP Morgan Life Sciences Private Capital and Samsara BioCapital. The company operates with a small leadership team and uses Launch Therapeutics and other service providers to scale clinical operations.

Name

Pathalys Pharma

Legal name

Pathalys Pharma, Inc.

Website

https://pathalys.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

1–10 employees

Short description

Pathalys Pharma is a private, late-stage clinical biopharmaceutical company developing upacicalcet, a novel intravenous calcimimetic, for treating secondary hyperparathyroidism in end-stage kidney disease patients receiving hemodialysis.

Ownership category

akta.pro rank

Product category

Nephrology Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule API Process Development & Route Scouting (HLAGAHAA)

akta.pro secondary industries

Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

Keywords

• Nephrology therapeutics
• Chronic kidney disease
• Calcimimetic drugs
• Secondary hyperparathyroidism
• Hemodialysis treatment

Headquarters

HQ city

Raleigh

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Once upacicalcet receives FDA approval, Pathalys plans to commercialize the drug directly, selling to dialysis providers and healthcare systems. The company retains worldwide commercial rights to upacicalcet outside Japan and Asia.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Pathalys Pharma is a private, late-stage clinical biopharmaceutical company developing upacicalcet, a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in patients with end-stage kidney disease on hemodialysis. The drug is administered as a bolus IV injection at the end of dialysis sessions via pre-filled syringe. Pathalys holds worldwide commercial rights outside Japan and Asia, where upacicalcet is already approved under the brand name UPASITA.

Product overview

Pathalys Pharma is a private, late-stage clinical biopharmaceutical company developing upacicalcet, a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients. The company operates a multi-asset strategy focused on end-stage kidney disease, with its lead product upacicalcet (designated PLS240 in clinical trials) being evaluated in the PATH Phase 3 clinical program. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group and holds worldwide commercial rights to upacicalcet outside Japan and Asia, where it is approved under the brand name UPASITA®.

Differentiator

Problem solved

Functional benefit

Products and services

• Upacicalcet Upacicalcet is a novel intravenous small molecule calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in end-stage kidney disease patients receiving hemodialysis. Administered as a bolus IV injection at the end of dialysis sessions via pre-filled syringe, it activates the calcium-sensing receptor to reduce parathyroid hormone (PTH) levels with potential for better tolerability compared to existing therapies.

Quantifiable outcome

• 67% of patients achieved mean iPTH between 60-240 pg/mL (vs 8% placebo)
• +3 more outcomes

Segments1 record

Ideal customer profiles1 record

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.

• Launch TherapeuticscoreStrategic or Co-development Partner · 18 January 2023Launch Therapeutics serves as the operational lead for execution and management of Pathalys' two Phase 3 clinical trials for upacicalcet. Launch Tx brings clinical development resources and expertise to accelerate the path to regulatory approval. Pathalys retains primary responsibility for manufacturing, FDA regulatory interactions, and commercialization. Launch Tx is backed by Carlyle and Abingworth.
• EA PharmacoreOEM/ Whitelabel/ Licensing Partner · 1 March 2022EA Pharma (subsidiary of Eisai) granted Pathalys an exclusive license to develop and commercialize upacicalcet worldwide outside of Japan and Asia. Upacicalcet was approved in Japan in 2021 under the brand name UPASITA.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Amgen: Markets Sensipar/Mimpara (cinacalcet, oral calcimimetic) and Parsabiv (etelcalcetide, IV calcimimetic) — the two established calcimimetics for SHPT in dialysis patients. Direct incumbent competitor to upacicalcet across both oral and IV segments of the same patient population.
• Ardelyx: Late-stage nephrology biopharma focused on CKD and dialysis-related indications (e.g., tenapanor for hyperphosphatemia). Comparable business model as a small, late-stage clinical biopharma targeting the same dialysis patient population.
• Akebia Therapeutics: CKD-focused biopharma developing vadadustat for anemia in CKD/dialysis; same end-customer (nephrologists and dialysis providers) and similar late-stage commercial build-out dynamics in the dialysis channel.
• Cara Therapeutics: Developed Korsuva (difelikefalin) for CKD-associated pruritus in hemodialysis patients — comparable late-stage biopharma with a dialysis-channel commercialization focus and similar payer/provider economics.

Broad incumbents

• Vifor Pharma: Established nephrology/specialty pharma company with iron deficiency franchise (Injectafer) and broader CKD/cardio-renal portfolio. Pathalys' COO Patrick Treanor was previously President US of Vifor, indicating direct comparability on commercial channels and customer base.
• Otsuka Pharmaceutical: Markets tolvaptan (Jynarque) for autosomal dominant polycystic kidney disease and has broader renal/cardiorenal portfolio. Comparable nephrology-focused commercial channel serving the same dialysis and CKD prescriber base.
• EA Pharma / Eisai: Original developer and Japan/Asia marketer of upacicalcet (UPASITA); Pathalys' licensor. Comparable as the reference commercial benchmark for the asset in a different geography and a related pharmaceutical manufacturer.

Emerging players

• Mineralys Therapeutics: Clinical-stage biopharma developing aldosterone synthase inhibitors for CKD and resistant hypertension; co-created by Catalys Pacific (same founder as Pathalys) — directly comparable as a sister CKD company with similar investor base and development philosophy.
• Chinook Therapeutics (Novartis): Rare kidney disease biopharma (acquired by Novartis for $3.5B in 2023) developing atrasentan and zigakibart for IgA nephropathy and other CKD indications. Comparable late-stage nephrology biopharma business model and CKD focus.
• Trevena: Small clinical-stage biopharma focused on CNS and specialty indications; comparable scale and late-stage development profile, with adjacent nephrology-relevant experience in specialty pharma commercialization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/PathalysPharma
• LinkedInlinkedin.com/company/pathalys

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds4 records

Investors11 records

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 Pathalys Pharma