Cristcot

What Cristcot does

Cristcot is a clinical-stage pharmaceutical company founded in 2008 and headquartered in Austin, Texas, focused on developing drug-device combination therapies for gastrointestinal diseases. Its lead asset, next-generation hydrocortisone acetate (ngHCA) 90mg suppository, is designed for rapid, localized treatment of ulcerative colitis flares of the rectum and is administered using the company's patented, FDA-cleared Sephure suppository applicator. The product was developed under a 505(b)(2) NDA pathway and is supported by a granted patent portfolio covering composition of matter, the Sephure device, manufacturing processes, and specialized drug assay testing methods; FDA accepted the NDA in April 2026 with a PDUFA target date of October 2026, and if approved, ngHCA would be the first and only FDA-approved HCA suppository.

The company's underlying technology is a vertically integrated drug-device platform: a small-volume, rapidly releasing suppository formulation paired with a proprietary applicator that targets precise placement and high patient adherence. Phase 3 CESSA trial data showed 23% clinical remission at Day 29 in the QD arm versus 2.1% placebo, with 97% compliance and no treatment-related serious adverse events. Cristcot is also advancing pipeline programs in acute pancreatitis, hemorrhoid disease, and other inflammatory GI indications built on the same formulation and delivery platform, and is operating under composition-of-matter patent protection extending into late 2036.

Cristcot is pre-revenue and pre-commercial, with primary customers expected to be gastroenterologists and the approximately 1.3 million U.S. ulcerative colitis patients with rectal disease involvement. Revenue mechanics will be traditional pharmaceutical product sales upon FDA approval, with commercial launch readiness targeted for Q4 2026 via a planned direct specialty sales force, supported by specialty pharmacy and distribution partnerships under evaluation. The company is founder-led (CEO Jennifer J. Davagian), privately held, and has assembled commercial leadership including a dedicated President of the HCA Commercial Division ahead of launch.

Name

Cristcot

Legal name

Cristcot

Website

https://cristcot.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Cristcot is a clinical-stage pharmaceutical company developing drug-device combination therapies for gastrointestinal diseases, with its lead candidate, the ngHCA suppository for ulcerative colitis, under FDA review (PDUFA October 2026) and targeted for Q4 2026 U.S. launch.

Ownership category

akta.pro rank

Product category

Gastroenterology Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Digestive Health OTC (Antacids, Laxatives, Anti-diarrheals, Probiotics OTC) (CRADAMAE)

Keywords

• Gastrointestinal therapeutics
• Ulcerative colitis treatment
• Drug-device combination
• Suppository drug delivery
• Pharmaceutical formulations

Headquarters

HQ city

Concord

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, Supply Chain, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Revenue will be generated from sales of ngHCA suppository upon FDA approval. The company is preparing for commercial launch with fourth quarter 2026 timing targeted. Pre-commercial stage with no current revenue.
2. Pipeline Products: Future revenue potential from diversified pipeline including programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Cristcot is a clinical-stage pharmaceutical company developing targeted drug-device combination therapies for gastrointestinal diseases. Its lead investigational product is the next-generation hydrocortisone acetate (ngHCA) 90mg suppository, administered using the patented FDA-cleared Sephure applicator, for treatment of ulcerative colitis of the rectum. The company also maintains a pipeline of development programs for acute pancreatitis, hemorrhoid disease, and other inflammatory gastrointestinal indications built on its patented drug formulation and delivery platforms.

Product overview

Cristcot is a clinical-stage pharmaceutical company developing targeted therapies for gastrointestinal diseases. The core product portfolio centers on the ngHCA (next-generation Hydrocortisone Acetate) 90mg suppository for ulcerative colitis treatment, delivered via the proprietary Sephure® suppository applicator. The company's pipeline includes investigational programs for acute pancreatitis, hemorrhoid disease, and other inflammatory GI conditions, all built on patented drug formulations and delivery platforms.

Differentiator

Problem solved

Functional benefit

Brands

• Sephure: Proprietary FDA-cleared suppository applicator used for administering Cristcot's HCA suppository therapy
• CESSA
• Cessa
• Synalax

Quantifiable outcome

• 23% clinical remission rate at Day 29 in QD treatment arm vs 2.1% placebo (p-value significant)
• +4 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered minor.

• Foley & Lardner LLPminorOthers · 12 January 2026Law firm providing comprehensive advice, regulatory guidance, and litigation support across healthcare, technology, manufacturing. Co-sponsored networking event 'An Evening With Friends' at J.P. Morgan Healthcare Conference 2026.
• ArmaninominorOthers · 12 January 2026Independent accounting and business consulting firm providing audit, tax, and advisory services. Co-sponsored networking event at J.P. Morgan Healthcare Conference 2026.
• Berkley Life SciencesminorOthers · 12 January 2026Specialty insurance provider offering property and casualty insurance and risk management solutions tailored for life sciences industry including pharmaceuticals, medical devices, and biotech. Co-sponsored J.P. Morgan Healthcare Conference networking event.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Prometheus Biosciences: UC-focused biotech acquired by Merck for ~$10.8B in 2023 with late-stage UC asset. Directly comparable as a single-asset, indication-focused biotech that scaled rapidly on positive Phase 3 UC data, providing a relevant M&A precedent for Cristcot.

Direct peers

• Arena Pharmaceuticals: Specialty pharma that developed etrasimod for ulcerative colitis and was acquired by Pfizer for ~$6.7B in 2022. Closely comparable as a single-indication UC drug developer with similar regulatory pathway dynamics; notably, Cristcot's CAO Jenny Gizzi previously held senior roles at Arena.
• RedHill Biopharma: Specialty pharmaceutical company focused on gastrointestinal diseases with both Rx and consumer GI products. Comparable as a small-cap GI-focused commercial-stage pharma with overlapping target indications and physician audience.
• Shorla Oncology: Specialty pharma commercializing oncology and rare disease products. Comparable as a similarly-sized, late-stage commercial-launch specialty pharma; notably, Rayna Herman (now Cristcot's HCA Commercial President) was previously CCO at Shorla.
• Tillotts Pharma: Specialty pharma focused on gastrointestinal diseases including ulcerative colitis products such as Mezavant. Comparable as a GI-pure specialty pharma with established gastroenterology commercial infrastructure and overlapping therapeutic area.

Broad incumbents

• Bausch Health (Salix Pharmaceuticals): Large GI specialty pharma franchise (Salix) covering UC, IBS, and related indications. Comparable as a broad GI specialty player with established gastroenterologist relationships and specialty distribution capabilities that Cristcot would need to replicate or partner with.
• Bristol-Myers Squibb: Major pharma with Zeposia (ozanimod) approved for UC. Broad incumbent competitor whose S1P modulator franchise competes directly in the UC maintenance and flare-treatment market Cristcot targets.
• Pfizer: Major pharma with etrasimod (acquired via Arena) and broader UC franchise. Represents the type of strategic acquirer for late-stage UC assets and a dominant competitor in the UC treatment paradigm Cristcot seeks to disrupt.
• Eli Lilly: Major pharma with Omvoh (mirikizumab) approved for UC. Broad incumbent competing for gastroenterologist mindshare and payer formulary access with substantial commercial resources Cristcot must contend with.
• AbbVie: Major pharma with Humira (adalimumab), Skyrizi, and Rinvoq franchises spanning UC. Sets the entrenched UC treatment paradigm and represents the highest bar Cristcot must overcome in physician adoption and payer access.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cristcot-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds6 records

Investors1 record

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 Cristcot