Steel Therapeutics

What Steel Therapeutics does

Steel Therapeutics, Inc. is a privately held, pre-revenue pharmaceutical development company headquartered in North Liberty, Iowa, and incorporated in Delaware in 2020 by Matt Stahl (CEO), Robbie Schwenker (CSO), and Allen Phillips (CFO), with Ben Clark later added as President and COO. The company's stated mission is to take therapies with a track record of efficacy in compounding pharmacies and bring them through the FDA approval process to increase standardization and patient access. Its sole named product candidate, Fizurex™, is a single-use disposable topical wipe delivering a combination of nifedipine (a calcium channel blocker that relaxes anal sphincter smooth muscle) and lidocaine (a local anesthetic) for the treatment of anal fissures — a condition for which today many patients rely on variable compounded preparations.

The technical core of Fizurex is a reformulation of two well-characterized, FDA-approved active pharmaceutical ingredients into a novel single-use wipe delivery system, intended to replace compounded creams and ointments with a regulated, dose-consistent, patient-friendly product. The company has received FDA pre-IND feedback indicating the agency does not object to the proposed development path, and as of mid-2025 Steel is running a pivotal toxicology study with CRO Altasciences to support an Investigational New Drug (IND) application targeted for early 2026.

Steel Therapeutics is pre-commercial and has no products on the market and no revenue. Its business model is contingent on future prescription pharmaceutical sales of Fizurex via physician prescription and standard US pharmacy distribution channels following FDA approval. Anticipated end users are patients with anal fissures, with prescribers including colorectal surgeons, gastroenterologists, and primary care physicians; the company also positions itself to capture demand currently served by compounding pharmacies. Steel has raised approximately $4.4 million across three disclosed SEC Rule 506(b) exempt offerings (2021, 2022, and 2025), and its longer-term ambition is to apply the same compounded-to-approved playbook to additional therapies, though no additional product candidates are publicly named.

Name

Steel Therapeutics

Legal name

Steel Therapeutics, Inc.

Website

https://steeltherapeutics.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Steel Therapeutics is a pre-revenue pharmaceutical development company pursuing FDA approval of Fizurex™, a single-use disposable topical wipe combining nifedipine and lidocaine to treat anal fissures, aiming to standardize therapies previously available only through compounding pharmacies.

Ownership category

akta.pro rank

Product category

Prescription Pharmaceuticals

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Sharps Safety, Needlestick Prevention & Disposal (Safety Devices, Sharps Containers) (HLAHANAH)

Keywords

• Topical pharmaceutical development
• Prescription drug development
• Compounding pharmacy therapies
• Anal fissure treatment
• FDA regulatory approval

Headquarters

HQ city

North Liberty

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, Others, Marketing or Sales

Revenue model

1. Future prescription pharmaceutical product sales (Fizurex™): Company is pre-revenue and pre-FDA approval. Future revenue will be generated through one-time sales of an FDA-approved prescription pharmaceutical product (Fizurex™) following successful clinical development and regulatory approval, targeted at patients with anal fissures via physician prescription.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Steel Therapeutics is developing Fizurex™, a single-use, disposable topical wipe that delivers a combination therapy of nifedipine (a calcium channel blocker) and lidocaine (a local anesthetic) for the treatment of anal fissures. The company is pursuing FDA approval to convert compounded versions of these drugs into a standardized, patient-friendly wipe format and is conducting a pivotal toxicology study in preparation for an IND application planned for early 2026.

Product overview

Steel Therapeutics is an Iowa-based pharmaceutical company built around a single lead product candidate, Fizurex™, a single-use disposable wipe delivering a nifedipine and lidocaine combination therapy for anal fissures. Beyond Fizurex™, the company has indicated a longer-term ambition to take other compounded therapies from compounding pharmacies through FDA approval using innovative delivery systems, but Fizurex™ is the sole named product in its current portfolio and is progressing through pivotal toxicology studies toward an IND application planned for early 2026.

Differentiator

Problem solved

Functional benefit

Brands

• Fizurex: Steel Therapeutics' first product candidate; a single-use, disposable wipe utilizing nifedipine and lidocaine combination therapy for anal fissures, being developed for FDA approval.

Quantifiable outcome

• Targeted IND filing in early 2026 to begin FDA-regulated clinical trials for Fizurex.

Segments3 records

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 and minor.

• AltasciencescoreImplementation/ SI/ Consulting PartnerAltasciences is a contract research organization (CRO) partnering with Steel Therapeutics to conduct toxicology studies supporting the development of Fizurex. This is a critical third-party service partnership to advance the product toward an IND filing.
• Iowa Startup AcceleratorminorGTM or Marketing PartnerSteel Therapeutics has participated in the Iowa Startup Accelerator, an ecosystem program that provides mentorship, visibility, and connections to investors and partners in the Iowa startup community.

Scale indicators7 records

Recent moves4 records

Expansion highlights5 records

Broad incumbents

• Mallinckrodt Pharmaceuticals: Specialty pharmaceutical company with a portfolio that includes dermatology and topical therapies. Relevant as a larger specialty pharma that pursues reformulation and repurposing strategies similar in spirit to Steel's Fizurex approach.
• Bausch Health: Parent of Salix Pharmaceuticals and other GI-focused specialty brands. Operates in the same gastroenterology therapeutic area and sells to many of the same physician segments that Steel Therapeutics would target post-approval.
• Salix Pharmaceuticals (Bausch Health): Large gastroenterology specialty pharmaceutical business within Bausch Health, with an established commercial infrastructure selling GI products to the same colorectal surgeon and gastroenterologist prescriber base that would prescribe Fizurex.
• Sebela Pharmaceuticals: Specialty GI-focused pharmaceutical company with a portfolio including treatments for anal fissures (e.g., nitroglycerin ointment) and other gastroenterology indications. Comparable as an established specialty pharma player operating in Steel's target therapeutic area.

Direct peers

• Norgine (RDD Pharma): Norgine acquired RDD Pharma, which developed and commercialized Rectiv (nifedipine 0.3% topical cream) — the only FDA-approved topical nifedipine product for chronic anal fissures. It is the most direct competitor to Steel Therapeutics' Fizurex, addressing the same indication with the same primary active ingredient in a different delivery format.

Regional players

• Almirall: European-focused dermatology and topical specialty pharmaceutical company that has historically marketed diltiazem cream for anal fissures in select European markets. Comparable as a topical therapy developer in the anal fissure space, although primarily outside the U.S. market Steel is targeting.

Emerging players

• Fagron: Global leader in pharmaceutical compounding, supplying APIs and compounded preparations to compounding pharmacies. Relevant as the upstream supplier ecosystem that today services the off-label nifedipine/lidocaine demand Steel is targeting to convert.
• Noven Pharmaceuticals: Specialty pharmaceutical company focused on transdermal and topical drug delivery technologies. Comparable in its focus on innovative delivery formats for known drug molecules — the same thesis Steel is applying with the Fizurex wipe.
• Harrow Health (ImprimisRx): Specialty pharmaceutical company that, through ImprimisRx, operates a compounding pharmacy business focused on ophthalmology and adjacent specialty areas. Comparable as a company that works at the intersection of compounding pharmacy practice and FDA-regulated product development.

Others

• Pfizer: Large multinational pharmaceutical company where Steel CEO/founder Matt Stahl previously worked. Relevant primarily as a talent-incubation reference point and as a representative of the Big Pharma commercial machinery that Steel will need to navigate via partnerships or licensing as it scales Fizurex post-approval.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/steel-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds4 records

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 Steel Therapeutics