Napo Therapeutics

What Napo Therapeutics does

Napo Therapeutics S.p.A. is a Milan-based, clinical-stage pharmaceutical company developing crofelemer, a first-in-class anti-secretory prescription drug derived from the sap of Croton lechleri (Dragon's Blood tree), a plant native to the Amazon rainforest. The drug targets rare gastrointestinal diseases — primarily Short Bowel Syndrome (SBS) and Microvillus Inclusion Disease (MVID) — where patients currently have no approved pharmacological treatment and are dependent on parenteral nutrition from birth or post-surgical onset. Clinical data from an investigator-initiated proof-of-concept trial demonstrated up to 37% reduction in parenteral support needs in pediatric patients with intestinal failure.

Crofelemer's mechanism reduces intestinal fluid secretion at the gut level, and its supply chain is built on over 20 years of ethnobotanical research and sustainable sourcing partnerships with indigenous communities in Peru. Approximately 800,000 Croton lechleri trees have been planted across seven regions since 2000, with at least 2-3 new trees planted per harvested tree, supporting a renewable botanical raw material base that is difficult to replicate on a comparable timeline. The company has advanced from investigator-initiated studies into company-sponsored registration-enabling trials (NCT06721871 for MVID, NCT06904872 for SBS-IF) across sites in the EU, UAE, and USA, with a targeted NDA filing by mid-2027.

Napo Therapeutics is a wholly-owned subsidiary of Napo Pharmaceuticals, itself a wholly-owned subsidiary of Jaguar Health Inc. (NASDAQ: JAGX). The company is pre-revenue and funds operations through parent company resources plus external investment, including a 2023 first investment tranche led by Sprim Global Investments that valued the company at €55 million. Napo's stated commercialization strategy is to obtain marketing authorization across Europe and commercialize crofelemer through traditional pharmaceutical channels targeting healthcare providers and specialized intestinal failure treatment centers, with the parent company simultaneously exploring licensing models and strategic alternatives including M&A.

Name

Napo Therapeutics

Legal name

Napo Therapeutics S.p.A.

Website

https://napotherapeutics.com/en/

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

Napo Therapeutics S.p.A. is a Milan-based, clinical-stage pharmaceutical company developing crofelemer, a first-in-class anti-secretory drug derived from Croton lechleri sap, for rare gastrointestinal diseases including Short Bowel Syndrome and Microvillus Inclusion Disease. It is a wholly-owned subsidiary of Jaguar Health (NASDAQ: JAGX).

Ownership category

akta.pro rank

Product category

Rare Disease Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Gastroenterology Specialty Pharmaceuticals (HLAIACAE)

akta.pro secondary industries

Rare Gastroenterology & Hepatology Disorder Therapies (HLAIAIAL), Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)

Keywords

• Rare disease therapeutics
• Gastrointestinal drug development
• Plant-based pharmaceuticals
• Orphan drug development
• Anti-secretory drug therapy

Headquarters

HQ city

Milano

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Drug Commercialization (Future): Napo Therapeutics is a clinical-stage company developing crofelemer for rare gastrointestinal diseases. The company plans to expand Crofelemer's market in Europe and aims for an initial public offering. Revenue will be generated through pharmaceutical product sales upon regulatory approval.
2. Licensing and Milestone Payments: Parent company Jaguar Health has shifted from direct sales to a licensing model, having entered an out-licensing agreement with Future Pak for Mytesi and Canalevia-CA1 products, receiving $18 million upfront plus potential milestone payments. This licensing model may inform Napo's future revenue strategy.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Napo Therapeutics is developing crofelemer, a first-in-class anti-secretory prescription drug derived from the sap of Croton lechleri (Dragon's Blood tree) native to the Amazon rainforest. The drug targets rare gastrointestinal diseases, specifically Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDD) including Microvillus Inclusion Disease (MVID), addressing critical unmet medical needs for patients with no approved pharmacological treatments.

Product overview

Napo Therapeutics is developing Crofelemer, a first-in-class prescription drug derived from the Croton lechleri (Dragon's Blood) plant found in the Amazon rainforest. The drug targets rare gastrointestinal diseases—specifically Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDD) including Microvillus Inclusion Disease (MVID). The company is currently conducting clinical trials in the EU, UAE, and USA, with plans to obtain marketing authorization across Europe.

Differentiator

Problem solved

Functional benefit

Products and services

• Crofelemer Crofelemer is a first-in-class anti-secretory prescription drug derived from the sap of Croton lechleri (Dragon's Blood tree) native to the Amazon rainforest. It is being developed for the treatment of rare gastrointestinal diseases including Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDD) such as Microvillus Inclusion Disease (MVID), targeting healthcare providers treating intestinal failure patients, with planned European marketing authorization.

Quantifiable outcome

• Up to 37% reduction in parenteral support in pediatric patients with MVID and SBS
• +2 more outcomes

Named customers2 records

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

Five partnerships are on record, tiered minor and core.

• Cleveland ClinicminorStrategic or Co-development PartnerConducts investigator-initiated Open-Label Pilot Study with Crofelemer in Patients with Short Bowel Syndrome (NCT06326645). Clinical trial conducted independently with crofelemer supply from Napo.
• Sheikh Khalifa Medical City (Abu Dhabi, UAE)minorStrategic or Co-development PartnerSponsor of Exploratory Single-Arm, Open-Label Non-Randomized Trial Evaluating Safety & Effectiveness of Crofelemer in Pediatric Patients with Intestinal Failure (IF). Investigator-initiated proof-of-concept study demonstrating 37% reduction in parenteral support.
• European healthcare sites (Germany, Italy)minorStrategic or Co-development PartnerNapo Therapeutics S.P.A. is enrolling adult SBS-IF patients in a randomized double-blind placebo-controlled trial (CRO-SBS-IF study) at clinical sites in Germany and Italy.
• Peruvian indigenous communities (Yanesha, Ashaninka, Awajun, Kichwa, Kandozi, Maijuna)coreStrategic or Co-development PartnerOver 20 years of collaboration with local communities and research institutions in the Peruvian Amazon for sustainable Croton lechleri cultivation and harvesting. Communities support reforestation, seed collection, and traditional knowledge sharing. Approximately 800,000 trees planted in seven regions of Peru.
• Research institutions in Colombia, Ecuador, and PeruminorStrategic or Co-development PartnerCollaboration with research institutions supporting the sustainable sourcing and ethnobotanical research of Croton lechleri for crofelemer production.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Ardelyx: Specialty GI biotech with approved tenapanor products (IBSRELA, XPHOZAH) targeting secretory GI mechanisms. Closely comparable business model as a focused GI specialty developer with a differentiated mechanism-of-action platform.
• Ironwood Pharmaceuticals: GI-focused specialty pharma (linaclotide/IBS-C) that acquired VectivBio and its SBS-IF asset apraglutide. Direct competitor in the SBS-IF space and a benchmark GI specialty commercial model.
• Zealand Pharma: Danish biotech developing glepaglutide, a GLP-2 analog for short bowel syndrome with intestinal failure — the same indication as Napo's lead crofelemer SBS-IF trial. Most direct mechanistic and indication competitor.

Broad incumbents

• Vertex Pharmaceuticals: Large-cap rare-disease biotech known for cystic fibrosis franchise and growing pipeline in serious specialty indications including GI. Comparable as a benchmark for clinical-stage rare-disease commercial execution and orphan pricing dynamics.
• Jaguar Health: NASDAQ-listed parent company of Napo Therapeutics (via Napo Pharmaceuticals) and the original developer of crofelemer, commercializing Mytesi and Canalevia-CA1 in adjacent GI indications. Most directly comparable entity for crofelemer's underlying IP, regulatory history, and commercial strategy.
• AbbVie: Global pharma with a meaningful rare-disease and GI franchise (post-Allergan) including linaclotide partnerships. Represents a realistic strategic acquirer/partner for an orphan GI asset at commercial inflection.
• Takeda Pharmaceutical: Global rare-disease leader (post-Shire acquisition) with established GI/intestinal-failure portfolio and orphan drug infrastructure. Represents the type of strategic acquirer or licensing partner relevant to Napo's commercial pathway.
• BioMarin Pharmaceutical: Established rare-disease biotech (enzyme replacement, gene therapy) with deep orphan-drug commercial expertise and European infrastructure. Comparable as a long-horizon rare-disease platform with similar regulatory and pricing dynamics.

Emerging players

• Ultragenyx Pharmaceutical: Mid-cap rare-disease biotech with a multi-asset pipeline spanning metabolic, neuro, and GI-adjacent indications. Comparable as a clinical-to-commercial rare-disease operator of similar size and stage profile.
• Tarsus Pharmaceuticals: Specialty pharma that successfully commercialized an orphan/rare-condition therapy (XDEMVY for Demodex blepharitis) via a focused specialty sales model. Comparable as a benchmark for launching a single-asset orphan therapy through a targeted specialty channel in Europe and the US.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/napo-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds1 record

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 Napo Therapeutics