What Ellodi Pharmaceuticals does

Ellodi Pharmaceuticals is a privately held, clinical-stage specialty pharmaceutical company founded in September 2020 by TPG Capital through a spin-out of the APT-1011 program from Adare Pharmaceuticals. The company is headquartered in Blue Bell, Pennsylvania, and is singularly focused on developing therapies for Eosinophilic Esophagitis (EoE), a rare, chronic allergic inflammatory disease of the esophagus characterized by dysphagia, food impaction, and strictures. The company estimates EoE prevalence at approximately 57 per 100,000 in the United States and notes that no FDA-approved orally administered treatments currently exist for the condition.

The company's core asset is APT-1011, a novel once-daily oral disintegrating tablet (ODT) that uses proprietary AdvaTab technology to deliver fluticasone propionate topically to the esophageal mucosa with low systemic absorption. The tablet is placed on the tongue at bedtime and dissolves in under 30 seconds before being swallowed to coat the esophagus. APT-1011 is the only fluticasone product in advanced clinical development for EoE and has received FDA Fast Track Designation (February 2021) and Orphan Drug Designation from both the FDA and EMA. The clinical program includes completed Phase 2b (FLUTE) and Phase 3 (FLUTE-2) studies, with the Phase 3 FLUTE-3 trial actively recruiting. Phase 3 data showed 27% complete symptomatic response at 12 weeks versus 11% on placebo (p=0.031) and 58.5% stricture resolution/improvement versus 25.0% on placebo. A second pipeline candidate, Esomeprazole ODT, is in Discovery stage.

Ellodi has no commercialized products and therefore no revenue. Its business model is contingent on FDA approval of APT-1011, after which revenue would be generated through pharmaceutical product sales, likely distributed via specialty pharmacies and gastroenterology-focused channels. The company maintains a small management team with deep specialty pharma and rare disease experience drawn from Adare, Synergy, Shire, Johnson & Johnson, Insmed, Novartis, and Takeda. Governance is controlled by TPG Capital (~$83B AUM), which holds three of seven board seats. Marketing and patient engagement are conducted through the corporate website, clinicaltrials.gov, medical conferences (DDW, ACG), LinkedIn, and partnerships with patient advocacy organizations (APFED, CURED, ausEE).

Name

Ellodi Pharmaceuticals

Legal name

Ellodi Pharmaceuticals

Website

https://ellodipharma.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Ellodi Pharmaceuticals is a clinical-stage, TPG Capital-backed specialty pharmaceutical company developing APT-1011, a novel oral disintegrating tablet for the treatment of Eosinophilic Esophagitis (EoE), currently in Phase 3 trials with FDA Fast Track and Orphan Drug Designations.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Clinical Trial Pharmacy & IMP Management at Site (HLAGACAK)

Keywords

• Specialty pharmaceuticals
• Eosinophilic esophagitis treatment
• Oral disintegrating tablets
• Fluticasone propionate formulation
• Gastroenterology drug development

Headquarters

HQ city

Blue Bell

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Once APT-1011 receives FDA approval, Ellodi Pharmaceuticals will generate revenue through the sale of prescription pharmaceutical products for the treatment of Eosinophilic Esophagitis. The company is currently in Phase 3 clinical trials and has not yet commercialized any products.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Ellodi Pharmaceuticals is a clinical-stage specialty pharmaceutical company developing APT-1011, a novel once-daily oral disintegrating tablet (ODT) that delivers fluticasone propionate to the esophageal mucosa for the treatment of Eosinophilic Esophagitis (EoE). The product is currently in Phase 3 clinical trials (FLUTE 3) and has received FDA Fast Track Designation plus Orphan Drug Designation from both the FDA and EMA. The company also has Esomeprazole ODT in its early-stage pipeline for EoE.

Product overview

Ellodi Pharmaceuticals is a gastroenterology-focused specialty pharmaceutical company developing therapies for Eosinophilic Esophagitis (EoE). The company's primary product is APT-1011, a novel once-daily oral disintegrating tablet delivering fluticasone propionate to the esophageal mucosa. The FLUTE clinical trial program (FLUTE 1 Phase 2b, FLUTE 2 Phase 3, and ongoing FLUTE 3 Phase 3) supports APT-1011's development. The company also has Esomeprazole ODT in its pipeline at the Discovery stage. No FDA-approved orally administered treatments for EoE currently exist.

Differentiator

Problem solved

Functional benefit

Products and services

• APT-1011 APT-1011 is a novel, once-daily, oral disintegrating tablet (ODT) designed to deliver fluticasone propionate to the esophageal mucosa to exert local anti-inflammatory effects with low systemic absorption for the treatment of Eosinophilic Esophagitis (EoE) in adults, adolescents, and children. The tablet is placed on the tongue at bedtime and melts in under 30 seconds before being swallowed to coat the esophagus. Currently in Phase 3 clinical trials (FLUTE 3) with FDA Fast Track Designation and FDA/EMA Orphan Drug Designation.
• Esomeprazole ODT Esomeprazole ODT is an oral disintegrating tablet formulation in Ellodi's pipeline for the treatment of Eosinophilic Esophagitis. Currently in Discovery stage of development.

Quantifiable outcome

• 27% complete symptom response rate at 12 weeks with APT-1011 vs 11% with placebo (p=0.031)
• +3 more outcomes

Segments1 record

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Four partnerships are on record, tiered core and support.

• Adare PharmaceuticalscoreStrategic or Co-development Partner · 22 September 2020Ellodi Pharmaceuticals was formed through a transaction that spun-out select clinical assets from Adare Pharmaceuticals, specifically the APT-1011 program and related science. Adare's Global Head of Specialty Pharma, Troy Hamilton, assumed the role of Ellodi CEO. The formation extended TPG Capital's decade-long partnership with Adare.
• American Partnership for Eosinophilic Disorders (APFED)supportOthersPatient advocacy organization focused on embracing, supporting, and improving the lives of patients and families affected by eosinophil-associated diseases through education, awareness, research, support, and advocacy. Listed as a patient advocacy group resource on Ellodi's patient resources page.
• Campaign Urging Research for Eosinophilic Disease (CURED)supportOthersPatient advocacy organization committed to raising substantial funding for research advocating on behalf of EGID patients and families, working to educate and increase awareness about eosinophilic diseases. Listed as a patient advocacy group resource on Ellodi's patient resources page.
• ausEE, Inc.supportOthersAustralian patient advocacy organization improving the lives of those affected by eosinophilic gastrointestinal disorders by providing support, evidence-based information, resources, and campaigning to raise awareness and funds for further research. Listed as a patient advocacy group resource on Ellodi's patient resources page.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Sanofi/Regeneron: Dupilumab (Dupixent) was approved by the FDA in 2024 for Eosinophilic Esophagitis, making Sanofi/Regeneron the first biologic approved for EoE and the most directly competitive therapeutic option for APT-1011 in the same indication.
• Dr. Falk Pharma: Dr. Falk Pharma developed and markets budesonide orodispersible tablet (Jorveza) in Europe for EoE induction therapy, the most direct orally-administered topical steroid competitor to APT-1011 in the same disease and route of administration.
• AstraZeneca: AstraZeneca's benralizumab (Fasenra) is being investigated for EoE and targets the IL-5 pathway; this represents a competing biologic therapy approach in the same EoE indication pursued by Ellodi.
• Bristol Myers Squibb: BMS is developing cendakimab and other IL-23/IL-13 pathway inhibitors for EoE, directly competing with APT-1011's oral fluticasone approach in the same indication through complementary biologic mechanisms.
• GlaxoSmithKline: GSK's mepolizumab (Nucala) has been evaluated for EoE via the IL-5 pathway, representing another competing therapeutic mechanism in the same rare inflammatory gastrointestinal disease space as Ellodi's APT-1011.

Broad incumbents

• Takeda Pharmaceutical: Takeda is a major gastroenterology-focused pharmaceutical company developing/positioning therapies in EoE (e.g., Lanifibranor-adjacent programs and legacy Shire gastroenterology assets) and represents a broad incumbent with overlapping GI and rare disease capabilities.

Emerging players

• RedHill Biopharma: RedHill Biopharma is a specialty pharmaceutical company focused on gastrointestinal diseases with approved products like Talicia and Aemcolo, making it a smaller emerging player comparable to Ellodi's specialty pharma positioning in GI.
• Phathom Pharmaceuticals: Phathom is a gastroenterology-focused emerging pharmaceutical company with approved products Voquezna (vonoprazan) for GERD/H. pylori, making it directly comparable as a specialty GI pharma targeting conditions adjacent to EoE with novel mechanisms.
• Allakos: Allakos is a clinical-stage biotech developing lirentelimab (anti-Siglec-8) targeting eosinophilic diseases including EoE, representing an emerging biologic competitor in the same eosinophil-driven disease category as Ellodi.

Others

• Adare Pharmaceuticals: Adare Pharmaceuticals is the originator of APT-1011 and spin-out source of Ellodi's assets (formed in 2020 TPG transaction), making it a direct enabling/originator relationship and the historical counterparty for the technology platform used by Ellodi.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/ellodipharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 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 Ellodi Pharmaceuticals