Our solutions

Innovation. Science. Care.

Our product and pipeline portfolio brings together advanced drug delivery technologies - including proprietary MMX® oral formulations - and AI-enabled medtech platforms. We focus on supporting therapeutic innovation across gastroenterology, dermatology, and endoscopic diagnostics by developing and enabling solutions designed to meet evolving clinical needs and regulatory standards.

Each program is grounded in scientific rigor, from established treatments for chronic conditions to digital systems applied in procedural medicine. Our commitment extends from early-stage research through to clinical application, always with a view to supporting healthcare professionals and the patients they serve.

At every step, we strive to advance care with dedication and responsibility, guided by the needs of clinicians, patients, and the broader healthcare community.

MMX® Technology

MMX® technology is a proprietary multi-matrix system designed to enable targeted and controlled release of active ingredients directly to the colon. By facilitating site-specific delivery, MMX® supports treatment strategies where localized drug exposure is considered clinically appropriate. This approach is intended to optimize therapeutic benefit while limiting systemic absorption, aligning with the goal of safe and effective care.

Our solutions

GI Genius™

Therapeutic Area

Gastroenterology/AI-Assisted Endoscopy

Technology Platform

Deep learning computer-assisted detection system

Regulatory Status

CE Mark (EU), FDA (US), TGA (Australia), Health Canada, MHRA (UK)

Developer/Partnership

Cosmo Pharmaceuticals (MedTech AI Division)

Indication

AI-assisted detection of colorectal lesions during colonoscopy

Patient Information

Device information: FDA 510(k) database and manufacturer labeling

Safety Reporting

Device incidents: FDA MedWatch: fda.gov/medwatch

Eleview®

Therapeutic Area

Gastroenterology/Endoscopy

Technology Platform

Injectable solution with methylene blue for tissue visualization

Regulatory Status

FDA (2015), EMA (2016), Health Canada (2019), PMDA Japan (2020)

Developer/Partnership

Cosmo Pharmaceuticals

Indication

Submucosal injection for endoscopic resection of polyps and mucosal lesions

Patient Information

FDA device labeling available at: accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Safety Reporting

Device incidents: FDA MedWatch: fda.gov/medwatch

Winlevi® (clascoterone cream 1%)

Therapeutic Area

Dermatology

Regulatory Status

FDA (August 2020), Health Canada (2023), TGA Australia (2024)

Developer/Partnership

Cosmo Pharmaceuticals

Indication

Topical treatment of acne vulgaris in patients aged 12 years and older

Patient Information

FDA labeling: dailymed.nlm.nih.gov | Health Canada product monographs

Pharmacovigilance

Adverse events: pharmacovigilance@cassiopea.com | FDA MedWatch: fda.gov/medwatch

Lialda® / Mezavant® / Mesavancol®

Therapeutic Area

Gastroenterology

Technology Platform

MMX® Multi Matrix System for targeted colonic delivery

Regulatory Status

FDA approved (2007), various international markets

Developer/Partnership

Cosmo Pharmaceuticals

Indication

Treatment of ulcerative colitis in adults and pediatric patients (≥24 kg)

Patient Information

FDA labeling: dailymed.nlm.nih.gov | EMA product information

Uceris® (US) / Cortiment® (EU and international)

Therapeutic Area

Gastroenterology

Technology Platform

MMX® Multi Matrix System for colonic delivery

Regulatory Status

Approved in US, EU, and international markets

Developer/Partnership

Cosmo Pharmaceuticals

Indication

Treatment of active, mild to moderate ulcerative colitis

Patient Information

FDA/EMA labeling via national regulatory websites

Rifamycin SV MMX® (Aemcolo® / Dotecine®/ Stadmycin®)

Therapeutic Area

Gastroenterology/Infectious Disease

Technology Platform

MMX® targeted colonic delivery system

Regulatory Status

FDA approved (Aemcolo®), EMA approved (Dotecine®/ Stadmycin®)

Developer/Partnership

Cosmo Pharmaceuticals

Indication

Treatment of travelers' diarrhea caused by non-invasive E. coli

Patient Information

FDA/EMA approved product labeling and patient leaflets

Pharmacovigilance

Adverse events: +39 02 9333 7980 or cosmotechaemcolo@cosmohc.com

Lumeblue® (China / Global) / Methylene Blue MMX® (EU)

Therapeutic Area

Gastroenterology/Endoscopy

Technology Platform

MMX® oral delivery system for targeted colonic release

Regulatory Status

EMA approved (August 2020), NMPA China approved (June 2024)

Developer/Partnership

Cosmo Pharmaceuticals

Indication

Visual enhancement during colonoscopy for detection of colorectal lesions

Patient Information

EMA product information, NMPA approved labeling

Pharmacovigilance

Adverse events: pharmacovigilance@cassiopea.com

Pipeline

Our development pipeline is guided by a commitment to addressing areas of significant unmet need. We apply proprietary technologies and draw upon robust clinical trial data to advance targeted solutions in gastroenterology, dermatology, and other areas of focus. Each investigational program is developed with a focus on scientific rigor, patient safety, and the requirements of healthcare professionals.

Throughout every stage, we remain dedicated to responsible innovation - supporting better care for patients.

Development pipeline: 
current focus areas

Therapeutic area

Program

Clinical need

Pre-clinical

Phase 1

Phase 2

Phase 3

Dermatology Androgenetic Alopecia (AGA)

Clascoterone

Male pattern hair loss affects ~50% of men over 50 globally.

Status: Clinical trials ongoing for male pattern hair loss

Gastroenterology Distal Ulcerative Colitis / Proctitis

Novel UC Treatment

Targeted therapy for distal inflammatory bowel disease.

Status: Clinical evaluation of treatment approaches

Gastroenterology Bile Acid Diarrhea (BAD)

BAD Treatment (CB-01-33)

Chronic diarrheal conditions affecting ~1% of population.

Status: Clinical studies investigating colesevelam formulation

Oncology Solid Tumors (Pancreatic & Colon Cancer)

CB-03-10

Pancreatic and colorectal malignancies.

Status: Clinical research exploring AR antagonist approaches

Program

Clinical application

Unmet need

Concept & feasibility

Design & development

Verification & validation

Regulatory approval

AI-Augmented Endoscopy

Our AI platform is continuously evolving to support broader clinical applications, deepen diagnostic precision, and enhance real-time decision-making during endoscopic procedures.

Supporting clinical decision-making across the 225+ million endoscopic procedures performed globally annually, with particular focus on the 50+ million colonoscopies where AI can address the clinical challenge that 22-30% of adenomas may be missed during standard examination. [1-8]

APP 1

APP 2

APP 3

Upper GI

Reporting

Others

1

SkyQuest Technology Consulting. Endoscopy procedures market size, share & trends 2023–2030. Endoscopy Procedures Market Report. 2022. In 2022, the global market for endoscopy procedures was valued at 225.3 million procedures. Available from: https://www.skyquestt.com/report/endoscopy-procedures-market/market-size

2

Grand View Research. Endoscopy procedures estimates market size report, 2030. Endoscopy Procedures Estimates Market. 2024. The global endoscopy procedures estimates market size was estimated at 191.1 million procedures in 2024 and is projected to reach 207.5 million procedures by 2030. Available from: https://www.grandviewresearch.com/industry-analysis/endoscopy-procedures-estimates-market-report

3

Ahn SB, Han DS, Bae JH, et al. The miss rate for colorectal adenoma determined by quality‑adjusted, back‑to‑back colonoscopies. Gut Liver. 2012;6(1):64‑70. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC3286741/

4

Rex DK, Cutler CS, Lemmel GT, et al. Colonoscopic miss rates of adenomas determined by back‑to‑back colonoscopies. Gastroenterology. 1997;112(1):24‑28. Available from: https://pubmed.ncbi.nlm.nih.gov/8978338/

5

Hong SN, Park JY, Han JP, et al. Adenoma miss rate determined by very shortly repeated colonoscopy after polypectomy. Medicine (Baltimore). 2018;97(38):e12376. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC6160154/ or https://journals.lww.com/md-journal/fulltext/2018/09210/adenoma_miss_rate_determined_by_very_shortly.23.aspx

6

Bisschops R, East JE, Hassan C, et al. Lower adenoma miss rate of computer‑aided detection‑assisted colonoscopy versus routine colonoscopy in a randomized trial. Gastroenterology. 2020;159(3):1252‑1261.e3. Available from: https://pubmed.ncbi.nlm.nih.gov/32562721/

7

Park SK, Kim HS, Yang HJ, et al. Miss rate of colorectal neoplastic polyps and risk factors for missed polyps in consecutive colonoscopies. Intest Res. 2017;15(3):411‑418. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC5478767/

8

Hong SN, Park JY, Han JP, et al. Adenoma miss rate determined by very shortly repeated colonoscopy after polypectomy. Medicine (Baltimore). 2018;97(38):e12376. Available from: https://journals.lww.com/md-journal/fulltext/2018/09210/adenoma_miss_rate_determined_by_very_shortly.23.aspx