Cristcot

Cristcot

Clinical-stage gastroenterology drug-device company

Overview

Cristcot focuses on gastroenterology by combining a disposable rectal-suppository applicator with drug formulations. Its Sephure applicator is FDA-cleared and lets air escape during insertion and withdrawal to ensure proper placement and reduce leakage, enabling use with various suppositories. The company develops drug–device combinations, led by a hydrocortisone acetate 90 mg suppository for ulcerative colitis delivered with Sephure, pursuing 505(b)(2) formulations. Its goal is to bring combined products to market and expand its pipeline for ulcerative colitis, acute pancreatitis, and hemorrhoids through clinical development and fundraising.

Significant Headcount Growth

About Cristcot

Simplify's Rating
Why Cristcot is rated
C+
Rated B on Competitive Edge
Rated B on Growth Potential
Rated D+ on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

Early VC

Total Funding

$22.5M

Headquarters

Austin, Texas

Founded

2008

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Simplify's Take

What believers are saying

  • FDA accepted ngHCA’s NDA on April 21, 2026, validating the Phase 3 package.
  • Rayna Herman’s May 6, 2026 hire accelerates launch readiness and commercial execution.
  • Revelio counted 49 employees in March 2026, showing hiring momentum before launch.

What critics are saying

  • FDA rejection in October 2026 kills Cristcot’s only near-term commercial asset.
  • WuXi Clinical Development’s 2023 contract lawsuit still clouds manufacturing and partner trust.
  • Single-asset dependence makes any ngHCA delay existential before 2027 financing.

What makes Cristcot unique

  • Sephure’s FDA-cleared applicator pairs device usability with Cristcot’s drug delivery moat.
  • ngHCA’s October 2026 PDUFA could create the first FDA-approved hydrocortisone acetate suppository.
  • Cristcot built a 505(b)(2) gastroenterology platform around rectal, patient-centric formulation expertise.

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Funding

Total Funding

$22.5M

Above

Industry Average

Funded Over

4 Rounds

Early VC funding comparison data is currently unavailable. We're working to provide this information soon!
Early VC Funding Comparison
Coming Soon

Growth & Insights and Company News

Headcount

6 month growth

↑ 14%

1 year growth

↑ 8%

2 year growth

↓ -1%
Associated Press
May 6th, 2026
Cristcot appoints Rayna Herman as president of hydrocortisone acetate commercial division

Cristcot, a clinical-stage pharmaceutical company focused on gastrointestinal diseases, has appointed Rayna Sethi Herman as president of its hydrocortisone acetate commercial division. Herman will oversee launch execution and strategy for the company's next-generation hydrocortisone acetate 90-milligram suppository, currently under FDA review. Herman joins from Shorla Oncology, where she served as chief commercial officer, building US commercial infrastructure and launching three branded products that delivered significant revenue growth in 2025. She previously held commercial roles at EVERSANA and Merck. The Austin-based company's lead asset would become the first FDA-approved hydrocortisone acetate suppository if cleared. Cristcot's pipeline includes investigational programmes for ulcerative colitis, acute pancreatitis and haemorrhoid disease.

Citybiz
Jun 10th, 2025
Cristcot Appoints Richard Kim as Chief Commercial Officer

Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced the appointment of Richard Kim to the role of Chief Commercial Officer.

Scientia Ventures
Oct 10th, 2023
Portfolio

Transforming the funding of life sciences through collaborative capital, Royalty Pharma developed and is the leader in the pharmaceutical royalty business.

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