What Sebela Pharmaceuticals does

Sebela Pharmaceuticals is a privately held U.S. specialty pharmaceutical company headquartered in Roswell, Georgia, with an international office in Dublin, Ireland. The company focuses on two therapeutic areas: Gastroenterology, anchored by Braintree Laboratories (founded 1983, acquired by Sebela in May 2018), and Women's Health, operated through its Sebela Women's Health division. Its core marketed and pipeline products include MIUDELLA, a hormone-free copper intrauterine system FDA-approved in February 2025 (the first in the U.S. in over 40 years); a 52 mg Levonorgestrel IUD currently in Phase 3-ready development; BLI5100 (tegoprazan), a novel potassium-competitive acid blocker (P-CAB) for GERD with an NDA submitted to the FDA in January 2026; and NTCD-M3, a Phase 2-stage product for prevention of recurrent C. difficile infection. Sebela's commercial platform is built on a targeted U.S. sales force promoting products to healthcare providers, supplemented by international distribution through marketing partners and licensing deals (notably the 2026 exclusive global licensing of MIUDELLA to Organon).

The company's technology platforms are differentiated: the SLIMSERT design and flexible nitinol frame allow a 3.7 mm insertion tube and anatomical conformity for its IUD family, while tegoprazan's P-CAB mechanism binds closer to the lumen of the parietal cell H+/K+-ATPase for faster onset versus PPIs. Sebela holds at least 15 granted U.S. patents covering the MIUDELLA system. In November 2025 the company divested its bowel-prep franchise (GoLYTELY, NuLYTELY, SUFLAVE, SUPREP, SUTAB) to Azurity Pharmaceuticals, concurrently transitioning more than 50 commercial employees, in order to concentrate capital and execution on the GERD and Women's Health pipeline.

Sebela earns revenue through three channels: direct pharmaceutical product sales to U.S. healthcare providers via its targeted sales force; licensing and royalty revenue (the Organon agreement provides a $27.5 million upfront payment, up to $505 million in sales-based milestones, and tiered double-digit royalties on net sales of MIUDELLA); and historical one-time transaction proceeds such as the Azurity divestiture. With 101–250 employees, a board that includes senior private equity operating partners (Metalmark Capital, DFW, Melkonian Capital), and a stated active business development mandate to acquire or in-license late-stage assets in GI and Women's Health, Sebela is structured as a focused specialty pharma built around two differentiated assets approaching commercialization.

Name

Sebela Pharmaceuticals

Legal name

Sebela Pharmaceuticals

Website

https://sebelapharma.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

akta.pro secondary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

Keywords

• Prescription pharmaceuticals
• Gastroenterology treatments
• Women's health therapeutics
• Intrauterine devices
• Acid reflux medication

Headquarters

HQ city

Roswell

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. Pharmaceutical Product Sales: Sebela markets pharmaceutical products to healthcare providers and distributes them throughout the United States. Many products are sold outside the U.S. by international marketing partners.
2. Licensing and Royalty Revenue: The company generates revenue through licensing agreements with milestone payments and ongoing royalties. For MIUDELLA, Organon paid $27.5 million upfront with potential milestone payments up to $505 million plus tiered double-digit royalties based on net sales.
3. Asset Divestiture: Sebela divested its Bowel Prep Franchise to Azurity Pharmaceuticals, strengthening Azurity's gastroenterology portfolio while Sebela focuses on its novel GERD treatment and other core products.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Sebela Pharmaceuticals develops, manufactures, and commercializes branded prescription pharmaceuticals in two therapeutic areas: Gastroenterology (lead GERD asset tegoprazan/BLI5100, a P-CAB with NDA submitted; investigational NTCD-M3 for recurrent C. difficile) and Women's Health (FDA-approved MIUDELLA hormone-free copper IUS and a Phase 3-ready 52 mg levonorgestrel hormonal IUD). The company sells these products primarily to U.S. healthcare providers via a targeted sales force and supplements reach through international marketing and licensing partners (e.g., Organon for MIUDELLA).

Product overview

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women's Health. The company's product portfolio spans two core therapeutic areas: (1) Women's Health - featuring MIUDELLA®, an FDA-approved hormone-free copper IUD (first in over 40 years), and a Phase 3 ready 52 mg Levonorgestrel hormonal IUD; (2) Gastroenterology - featuring BLI5100 (Tegoprazan), a P-CAB for GERD treatment with NDA submitted to FDA, and NTCD-M3 for C. diff prevention in Phase 2. The company operates through its Braintree affiliate for GI products and Sebela Women's Health for contraceptive products. The bowel prep franchise was divested to Azurity Pharmaceuticals in November 2025.

Differentiator

Problem solved

Functional benefit

Brands

• MIUDELLA: Copper-containing intrauterine system (IUS) for hormone-free pregnancy prevention, FDA-approved for up to 3 years use.
• BLI5100 (Tegoprazan)
• 52 mg Levonorgestrel IUD

Products and services

• MIUDELLA® (copper intrauterine system) FDA-approved hormone-free copper intrauterine system indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Made of nitinol with flexible and super-elastic properties that conform to different uterine shapes and sizes, containing less than half the copper of existing copper IUDs. Features 99% effectiveness and SLIMSERT technology with a 3.7mm insertion tube; intended for prescription by healthcare providers in the U.S. and distributed under a REMS program.
• 52 mg Levonorgestrel IUD Hormonal levonorgestrel-releasing long-acting reversible contraceptive in Phase 3-ready development, differentiated from existing hormone-releasing IUDs by a next-generation flexible nitinol frame that conforms to different uterine shapes and sizes. Features include a fully preloaded IUD in inserter, 3.7mm small insertion tube diameter with tapered rounded tip, and precut retrieval strings. Aimed at U.S. women's health prescribers and patients seeking a next-generation hormonal LARC option.
• BLI5100 (Tegoprazan)

Quantifiable outcome

• 99% effectiveness for pregnancy prevention for up to 3 years
• +4 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• OrganoncoreOEM/ Whitelabel/ Licensing Partner · 23 February 2026Organon acquired exclusive global licensing rights to MIUDELLA for $27.5 million upfront, up to $505 million in sales-based milestone payments, and tiered double-digit royalties. MIUDELLA is the first hormone-free copper IUD approved in the US in over 40 years. Organon leverages its established contraception expertise and commercial infrastructure to distribute the product globally, expected to be commercially available in late 2026.
• Azurity PharmaceuticalsminorStrategic or Co-development Partner · 17 November 2025Azurity Pharmaceuticals completed acquisition of Sebela's Bowel Prep Franchise, including two leading bowel preparation therapies for colonoscopies (GoLYTELY, NuLYTELY, SUFLAVE, SUPREP, SUTAB). Over 50 colleagues from Sebela's commercial and support teams joined Azurity. The transaction strengthens Azurity's presence in Gastroenterology.
• Braintree LaboratoriescoreOthersBraintree Laboratories is a specialty pharmaceutical company founded in 1983 in Braintree, Massachusetts, committed to colonoscopy preparation products. Acquired by Sebela Pharmaceuticals in May 2018, Braintree is a part of Sebela Pharmaceuticals focused on Gastroenterology and developed tegoprazan (BLI5100).
• American Society for Gastrointestinal Endoscopy (ASGE)minorOthersBraintree, a part of Sebela Pharmaceuticals, is a proud supporter of ASGE as part of its corporate partnership program.
• American College of Gastroenterology (ACG)minorOthersBraintree, a part of Sebela Pharmaceuticals, is a proud supporter of ACG as part of its corporate partnership program.
• American Gastroenterological Association (AGA)minorOthersBraintree, a part of Sebela Pharmaceuticals, is a proud supporter of AGA as part of its corporate partnership program.
• American Foregut SocietyminorOthersBraintree, a part of Sebela Pharmaceuticals, is a proud supporter of the American Foregut Society as part of its corporate partnership program.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• CooperSurgical: CooperSurgical, the women's health device arm of CooperCompanies, sells IUDs and related reproductive health products. It overlaps with Sebela's contraceptive device business and competes directly in the LARC market, but with broader portfolio of fertility and surgical products.
• Salix Pharmaceuticals (Bausch Health): Salix is the established market leader in Gastroenterology specialty pharma within Bausch Health's broader portfolio. It overlaps with Sebela's GI franchise including bowel prep and acid-related products, but with much greater scale, broader portfolio, and entrenched U.S. sales infrastructure.
• Bayer (Women's Health/Pharma): Bayer is a global pharma major with Mirena and other leading hormonal IUDs in its women's health franchise. Bayer represents the largest incumbent in LARC and competitive threat to MIUDELLA's segment expansion, particularly in international markets.

Emerging players

• Agile Therapeutics: Agile Therapeutics is an emerging women's health company that commercialized Twirla, a hormone contraceptive patch. It overlaps with Sebela in women's health reproductive therapeutics and is comparable as a smaller emerging player competing in the contraception category.

Direct peers

• Ironwood Pharmaceuticals: Ironwood is a GI-focused specialty pharma commercializing Linzess (linaclotide). Both companies pursue acid-related and functional GI disorders with R&D-driven, specialty-sales-driven business models, making Ironwood the closest pure-play GI peer in scale and stage.
• Organon: Organon is a global women's health pharmaceutical company and Sebela's exclusive global licensee for MIUDELLA. Both companies operate in the contraception/reproductive health space and Organon's commercial infrastructure now drives MIUDELLA's market uptake directly tying Sebela's royalty economics to Organon's execution.
• TherapeuticsMD: TherapeuticsMD is a women's health specialty pharmaceutical company focused on hormone therapies and contraceptives. It competes for the same specialty physician channel and shares the women's health pipeline development model that Sebela pursues.
• Evofem Biosciences: Evofem is a women's health company that commercialized Phexxi, a hormone-free contraceptive. Its former CMO (Kelly Culwell) is now Sebela's Head of R&D Women's Health, evidencing direct talent overlap and adjacency in the hormone-free LARC category.
• Azurity Pharmaceuticals: Azurity is a specialty pharma company that just acquired Sebela's Bowel Prep Franchise in November 2025. Both companies focus on Gastroenterology and women's health and share similar go-to-market models targeting U.S. healthcare providers through specialty sales forces.

Others

• Exact Sciences: Exact Sciences is a leading GI diagnostics company (Cologuard) where Sebela's CCO Victor Parker previously served. While it focuses on diagnostics rather than therapeutics, Exact Sciences serves the same gastroenterology physician channel Sebela targets and represents a complementary, comparable specialty commercial infrastructure in GI.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries4 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sebela Pharmaceuticals