Jaguar Health, Inc.

Jaguar Health, Inc.

Overview

Jaguar Health, Inc. and its affiliates develop plant-derived prescription medicines for complex gastrointestinal (GI) diseases in humans and animals, with a focus on crofelemer-based therapies. The corporate family includes Napo Pharmaceuticals (human health), Napo Therapeutics (European development and licensing), Jaguar Animal Health (animal health), and Magdalena Biosciences (a joint venture with Filament Health for plant-based mental health medicines).

The company’s strategy centers on first-in-class, sustainably sourced gastrointestinal therapies built on a proprietary medicinal plant library and clinical and regulatory experience. Partnerships and licensing are central to advancing pipeline indications toward pivotal trials and potential commercialization.

Organization and key units

• Human health (Napo): Development and commercialization of crofelemer-based therapies, including Mytesi, and continued development of crofelemer-related programs such as NP-300 (a second-generation anti-secretory agent) and crofelemer powder formulations for rare diseases.
• Animal health (Jaguar Animal Health): Development and commercialization of canine GI products, including Canalevia-CA1 (crofelemer delayed-release tablets) for chemotherapy-induced diarrhea (CID) in dogs; Canalevia-CA1 has FDA conditional approval under an in-licensing arrangement.
• Magdalena Biosciences: U.S.-based joint venture with Filament Health to develop plant-derived medicines for mental health indications, initially targeting adult ADHD.
• Napo Therapeutics: EU-focused development and licensing, holding a European license to develop and sell crofelemer and NP-300 for short bowel syndrome with intestinal failure (SBS-IF) and related indications.

Core products and programs

• Mytesi (crofelemer 125 mg delayed-release tablets)
  • FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
  • Global rights historically held by Napo. A January 2026 license grants Future Pak exclusive U.S. marketing rights for Mytesi and Canalevia-CA1, while Jaguar continues manufacturing.
• Canalevia-CA1 (crofelemer delayed-release tablets) for CID in dogs
  • FDA conditional approval for CID in dogs (application 141-552) and MUMS designation from the FDA.
• Crofelemer powder for oral solution (intestinal failure indications)
  • Focus on orphan and ultra-rare intestinal failure indications: microvillus inclusion disease (MVID) in pediatrics and SBS-IF in adults.
  • Orphan Drug Designations in the U.S. and EU for MVID; ODD for SBS in the U.S. (Aug 2017) and EU (Dec 2021).
  • Development includes two pivotal trials (pediatric MVID and adult SBS-IF) in the U.S. and EU, with a pediatric MVID trial ongoing at multiple sites.
• NP-300 (second-generation anti-secretory agent)
  • Plant-based standardized extract, distinct from crofelemer, targeting moderate-to-severe diarrhea from bacterial, viral, and parasitic infections (including Vibrio cholerae).
  • Preclinical and clinical development in progress; potential tropical disease priority review voucher (TDPRV) opportunity; preclinical work supported by NIAID funding.
• Gelclair (oral mucositis treatment)
  • In-licensed from Venture Life Group and launched commercially in the U.S. in October 2024.
• Other pipeline programs
  • Programs include crofelemer-derived formats targeting IBS-D, infectious diarrhea, and other GI indications, supported by proanthocyanidin/polyphenol intellectual property and collaborations with key opinion leaders.

Intellectual property

Napo holds an extensive patent portfolio related to crofelemer and proanthocyanidin polymers from Croton spp. and Calophyllum spp., covering methods of treating HIV-associated diarrhea, CID, IBS-D, inflammatory bowel disease, SBS, congenital diarrheal disorders, and related indications. The portfolio comprises approximately 195 patents and related families, with multiple international filings covering manufacturing and treatment methods. License arrangements govern EU rights for SBS-IF, HIV-related diarrhea, and IF-related diarrhea.

Manufacturing and supply

Crofelemer API is sourced from plant latex of Croton lechleri, harvested under sustainable programs. The primary manufacturing relationship is with India-based Alivus Life Sciences Limited (formerly Glenmark Life Sciences Limited); Indena S.p.A. in Italy serves as a validated secondary manufacturing site. Indena is registered with AIFA (Italy) to supply crofelemer API for development and manufacturing.

Regulatory status and market incentives

The company pursues U.S. FDA and EU EMA pathways with emphasis on orphan designations and incentives available for orphan medicines, including market exclusivity, protocol assistance, and potential for accelerated or conditional approvals. Orphan Drug Designations exist for MVID (FDA Feb 2023; EMA Oct 2022) and SBS (FDA Aug 2017; EMA Dec 2021). The company has engaged in SPA discussions with the FDA for pivotal trial design and accounts for post-approval requirements such as REMS, post-market surveillance, and labeling considerations.

Licensing, partnerships, and funding

• Future Pak (U.S. licensing partner for Mytesi and Canalevia-CA1)
  • January 2026: Future Pak received exclusive U.S. marketing rights; Jaguar received $16 million in non-dilutive capital at closing and is eligible for up to $20 million in milestone payments plus additional future payments.
  • Jaguar will manufacture Mytesi and Canalevia-CA1 for Future Pak and maintain supply commitments.
  • March 2026: Jaguar received a $3.0 million payment from Future Pak following termination of a buy-back provision tied to the U.S. licensing agreement.
• Quadri Pharma (April 2022): Exclusive rights for specified human indications in the Gulf region (Bahrain, Kuwait, Qatar, Saudi Arabia, UAE, Oman) for Mytesi and related products under Named Patient Programs.
• Knight Therapeutics (September 2018): Exclusive rights to Mytesi and related products in Canada and Israel.
• Venture Life Group (April 2024): Exclusive 5-year in-license for Gelclair, now launched in the U.S.
• Napo Therapeutics EU license (August 2021): Rights to study and develop crofelemer and NP-300 in Europe for SBS-IF, HIV-related diarrhea, and IF-related diarrhea in congenital disorders.

People and facilities

• Employees: 47 as of December 31, 2025
  • 9 hold MD, DVM, and/or PhD degrees
  • 17 in research and development
  • 18 in sales and marketing
  • 4 employees located in Napo Therapeutics (Italy)
• Corporate headquarters: San Francisco, CA (200 Pine Street, Suite 400 for U.S. human health; Suite 600 for Jaguar Animal Health).
• Office footprint: 10,998 rentable square feet leased from M & E, LLC.
• Trademarks in use include Mytesi, Jaguar Health/Animal Health, Napo Pharmaceuticals, Napo Therapeutics, Canalevia, Gelclair, and Magdalena.

Market size and opportunity

• Mytesi: U.S. market potential for HIV-related diarrhea estimated at approximately $50 million in gross annual sales.
• Cancer therapy-related diarrhea (CTD) and CINV:
  • Approximately 650,000 U.S. cancer patients receive chemotherapy in outpatient settings (basis for CTD potential).
  • Global CINV market previously projected near $2.7 billion (cited data).
• SBS and MVID:
  • SBS market cited at over $568 million in 2019 with projections up to $4.6 billion by 2027 (Vision Research Reports).
  • IBS-D market potential cited above $1.0 billion.
• Infectious diarrhea and TDPRV context:
  • Historical TDPRV transactions have ranged roughly from $60 million to $350 million, providing context for NP-300’s potential value if a voucher is awarded.

Notable risk and development context

The company acknowledges regulatory and clinical risks, and dependence on clinical trial outcomes, FDA/EMA interactions, and partner and licensing arrangements. Data from the OnTarget pivotal trial showed a prespecified endpoint benefit in a breast cancer subgroup while not meeting the primary endpoint across all tumor types; Jaguar plans to submit a final clinical study report in the second half of 2026 with additional subgroup analyses and patient-reported outcomes.

Summary

Jaguar Health, Inc. and its affiliates focus on plant-derived, first-in-class GI therapies for humans and animals, led by crofelemer-based assets (Mytesi, Canalevia-CA1) and a crofelemer powder program for intestinal failure indications (MVID and SBS-IF). The company is advancing NP-300 and other related programs, pursuing global development through strategic licensing and partnerships, and maintaining a patent portfolio and multi-site manufacturing plan to support development and commercialization.