Delving into the Latest Updates on Cosmo Pharmaceuticals NV with Synapse

Overview

Tags

Digestive System Disorders

Immune System Diseases

Endocrinology and Metabolic Disease

Small molecule drug

Chemical drugs

Polymer

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	2
Neoplasms	2
Immune System Diseases	2
Infectious Diseases	2
Endocrinology and Metabolic Disease	2
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Small molecule drug	4
Chemical drugs	1
Polymer	1
Polysaccharide	1

Top 5 Target	Count

AR x GR	1
AR(Androgen Receptor)	1
factor Xa	1
rpoB(DNA-directed RNA polymerase beta chain)	1
Hemoglobins	1

A 6-month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-month Single-Blind Treatment With Clascoterone or Vehicle Solution

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects.
Within this study, the Clascoterone solution will be compared to a placebo.
The study has 2 parts:
Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months.
Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data.
Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving.
Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo.
Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months.
Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects).
For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls.
Subjects taking part in this study will have the medical tests or procedures described below.
* They will be asked about their previous medical history and current medications.
* A brief physical examination will be performed.
* Vital signs, weight and height will be measured.
* Electrocardiograms will be performed.
* Subject's scalp will be checked for any signs of irritation.
* Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness).
* Blood draws and urine sample collection for safety laboratory tests.
* Subject will be asked to complete, on site, the following two questionnaires:
* Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use.
* Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment.
Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening.
Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

Start Date17 Aug 2023

Sponsor / Collaborator

Cassiopea SpA

[+3]

NCT05910450

/ RecruitingPhase 3

A 6-month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-month Single-Blind Treatment With Clascoterone or Vehicle Solution

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects.
Within this study, the Clascoterone solution will be compared to a placebo.
The study has 2 parts:
Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months.
Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data.
Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving.
Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo.
Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months.
Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects).
For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls.
Subjects taking part in this study will have the medical tests or procedures described below.
* They will be asked about their previous medical history and current medications.
* A brief physical examination will be performed.
* Vital signs, weight and height will be measured.
* Electrocardiograms will be performed.
* Subject's scalp will be checked for any signs of irritation.
* Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness).
* Blood draws and urine sample collection for safety laboratory tests.
* Subject will be asked to complete, on site, the following two questionnaires:
* Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use.
* Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment.
Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening.
Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

Start Date21 Jun 2023

Sponsor / Collaborator

Cassiopea SpA

[+3]

100 Clinical Results associated with Cosmo Pharmaceuticals NV

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0 Patents (Medical) associated with Cosmo Pharmaceuticals NV

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16

Literatures (Medical) associated with Cosmo Pharmaceuticals NV

01 Jul 2025·AMERICAN JOURNAL OF GASTROENTEROLOGY

A Phase II, Multicentric, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of Efficacy and Safety of Rifamycin SV-MMX 600 mg Tablets Administered Three or Two Times Daily to Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Article

Author: Longo, Luigi ; Basilisco, Guido ; Santos, Javier ; Gentili, Alessandra ; Balsiger, Lukas Michaja ; Moro, Luigi ; Tack, Jan ; Gerloni, Mara ; Mazzetti, Alessandro ; Piessevaux, Hubert ; Serra, Jordi ; Baert, Didier ; Storr, Martin

INTRODUCTION::

Treatment with nonresorbable antibiotics is effective in diarrhea-predominant irritable bowel syndrome (IBS-D). Multimatrix (MMX) formulations ensure targeted drug delivery to the mid-distal small bowel and colon—traditionally considered the origin of IBS symptoms. To assess the efficacy of rifamycin SV-MMX for the treatment of IBS-D.

METHODS::

Randomized controlled trial in patients with IBS-D (Rome IV). Patients received rifamycin SV-MMX 600 mg (b.i.d = 1200 mg/d or t.i.d = 1800 mg/d) or placebo for 2 weeks. Primary end point was responder rate in the first treatment week on the full analysis set (FAS). Response was defined as decrease in average abdominal pain ≥ 30% AND ≥50% reduction of days with stool type 6 or 7 based on daily reporting.

RESULTS::

A total of 279 patients were randomized (=ITT), and 264 of were included in the FAS. More patients with rifamycin SV-MMX b.i.d (22/88, 25.00%) met the primary end point than t.i.d (10/81, 12.35%) or placebo (9/95, 9.47%) in both FAS and ITT. Adjusted odds ratio (AOR) for b.i.d. vs placebo was 3.26 (95% confidence interval (CI): 1.39–7.67; P = 0.007) and for t.i.d. vs b.i.d. 0.40 (95% CI: 0.17–0.92; P = 0.031). After treatment, the percentage of monthly global responders was higher in the b.i.d. group vs placebo in the first month (64.2% vs 46.6%, adjusted odds ratio = 2.14 95% CI: 1.15; 4.00; P = 0.0173) and first 2 months.

DISCUSSION::

Rifamycin SV-MMX 600 mg b.i.d. was more effective than placebo and t.i.d. dosing in the first week of treatment. Two months after treatment, rifamycin SV-MMX 600 mg b.i.d. provided more global symptom relief than placebo.

01 Nov 2020·MOLECULAR CANCER THERAPEUTICS

The Dual Androgen Receptor and Glucocorticoid Receptor Antagonist CB-03-10 as Potential Treatment for Tumors that have Acquired GR-mediated Resistance to AR Blockade

Article

Author: Moro, Luigi ; Rosette, Caridad ; Rosette, Niccolette ; Agan, Frances J. ; Gerloni, Mara ; Mazzetti, Alessandro

Abstract:

CB-03–10 (cortexolone 17α-valerate-21-propionate) is a synthetic steroidal compound derived from cortexolone (11-deoxycortisone), an intermediate in cortisol biosynthesis. Characterization of the activity of CB-03-10 and its main related compound CB-03–05 (cortexolone 17α-valerate) included in vitro binding to the androgen and glucocorticoid receptors (AR and GR), antagonism of AR and GR transcriptional activities, and screening for antitumor activity across a selected panel of human prostate and in triple-negative breast cancer cell lines. CB-03-10 cytotoxic activity in these cancer cell lines was in the low micromolar range and was primarily associated with induction of the apoptotic cascade via activation of caspases. The compound's potential for antitumor activity was verified in a murine xenograft model utilizing the AR-positive LNCaP prostate cancer cell line as well as in an orthotopic model utilizing AR-negative/GR-positive MDA-MB-231 breast cancer cell line. Orally administered CB-03-10 inhibited prostate tumor growth and orthotopically implanted breast tumor growth in these mice and maintained body weight, as compared with vehicle-treated mice. On the basis of AR/GR binding affinities, antagonism of androgen and glucocorticoid-dependent transcriptional activities, and AR/GR mRNA and protein expression, the mechanism of tumor growth suppression is related to AR and GR antagonist activities. Importantly, these compounds lack biologically relevant AR/GR agonist activities. Overall, these preclinical findings support the selection of CB-03-10 for further development as an anticancer agent in cases where resistance to AR-targeted therapy or chemotherapy, via upregulation of GR activity, continues to limit the efficacy and duration of clinical benefit with these interventions.

01 Jun 2019·Drug metabolism and pharmacokineticsQ4 · MEDICINE

Rifamycin SV exhibits strong anti-inflammatory in vitro activity through pregnane X receptor stimulation and NFκB inhibition

Q4 · MEDICINE

Article

Author: Gerloni, Mara ; Agan, Frances J ; Rosette, Caridad ; Rosette, Niccolette ; Moro, Luigi ; Mazzetti, Alessandro ; Hassan, Cesare

Rifamycin SV (rifamycin), is a member of the ansamycin family of antimicrobial compounds which kills bacteria commonly associated with infectious diarrhea and other enteric infections. Rifamycin has been found to be effective in experimental animal models of gut inflammation and its efficacy in these settings has been attributed partially to immunomodulatory non-bactericidal activities. This study aimed to further evaluate the anti-inflammatory activities of rifamycin by analyzing its effect on two key regulators of inflammation: PXR and NFκB. Rifamycin stimulated PXR transcriptional activity in two PXR reporter cell lines and induced expression of two genes known to be regulated by PXR and are directly involved in cellular detoxification: CYP3A4 and PgP. Moreover, CYP3A4 metabolic activity was induced by rifamycin in HepG2 cells. Rifamycin also antagonized TNFα and LPS-induced NFκB activities and inhibited IL1β-induced synthesis of inflammatory chemokine, IL8. Although reciprocal regulation of PXR and NFkB by rifamycin was not directly addressed, the data suggest that in the absence of PXR, inhibition of NFκB by rifamycin is not dependent on PXR stimulation. Thus, rifamycin exhibits potent anti-inflammatory activities, characterized by in vitro PXR activation and concomitant CYP3A4 and PgP induction, in parallel with potent NFκB inhibition and concomitant IL8 inhibition.

59

News (Medical) associated with Cosmo Pharmaceuticals NV

03 Dec 2025

·www.fiercepharma.com

Cosmo shares zoom with results from 2 male-pattern hair loss trials

The data suggest clascoterone could become the first “potential innovation in over 30 years in male hair loss,” Cosmo said. Cosmo Pharmaceuticals has revealed topline results from two phase 3 trials which indicate that its topical cream clascoterone could become a game-changing treatment for male-pattern hair loss.The parallel studies, which included 1,465 participants with male androgenetic alopecia (AGA) in 50 sites across Europe and the U.S., demonstrated statistically significant and clinically meaningful improvements in hair growth compared to placebo, the company said. One trial showed a 539% relative improvement in target-area hair count (TAHC) through six months, while the other trial showed a 168% gain versus placebo.The difference in the trial figures is driven “entirely by baseline hair counts, not by a difference in drug performance,” Cosmo CEO Giovanni Di Napoli said in an email. “When the two groups experience a similar absolute increase in hair count—but start from different baselines—the study with lower baseline values will show a larger relative percentage.”The treatment could become the first “potential innovation in over 30 years in male hair loss,” the Dublin-based company added.With the news, Cosmo shares were up 20%.“These data have the potential to redefine how dermatologists treat androgenetic alopecia worldwide,” Maria Hordinsky, M.D., of the University of Minnesota’s Department of Dermatology, said in a release.Cosmo's subsidiary Cassiopea scored FDA approved for clascoterone in 2020 as a treatment for acne. It is known commercially as Winlevi and is the top branded topical acne treatment in the U.S., Cosmo said (PDF) in its mid-year report, having drawn 1.4 million prescriptions since its launch in November of 2021.The first-in-class topical androgen receptor inhibitor blocks dihydrotestosterone (DHT) directly at the hair-follicle receptor without systemic absorption, targeting the root cause of male-pattern hair loss without the risks of oral therapies, Cosmo said. “For decades, patients have had to choose between available treatment options with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all,” Hordinsky added. “These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure.”Cosmo added that patient-reported outcomes further “reinforced the strength” of the topline results, with one study reaching statistical significance and the other showing a positive trend.Treatment-emergent adverse events (TEAEs) were similar across both studies, and similar to placebo, Cosmo added, with most TEAEs not related to clascoterone. After completion of a 12-month safety and durability study in the spring of next year, the company plans parallel submissions with the FDA and European Medicines Agency. Of the 166 million men in the U.S., 65 million have AGA, including 16 million who have been treated and 27 million who are seeking treatment, Cosmo said (PDF) in its most recent annual report. The company’s market research indicates it is a $20 billion opportunity in the U.S., Cosmo added on Wednesday.“At our investor day in July, Cosmo presented in-depth U.S. market research results showing an enormous, underserved demand,” Di Napoli said in a release. “These compelling data give us full confidence in respect to the upcoming regulatory submissions.”Cosmo describes itself as focused on MedTech AI, dermatology, gastrointestinal diseases and contract development and manufacturing (CDMO). The company reported 2024 revenue at 266 million euros ($310 million) for a 186% year-over-year increase.

Clinical ResultPhase 3Drug Approval

03 Dec 2025

·endpoints.news

Cosmo Pharmaceuticals’ shares rise after Phase 3 win in male pattern hair loss

Cosmo Pharmaceuticals’ shares increased 18% on the Swiss exchange Wednesday morning after it released positive late-stage results from its drug candidate in men with androgenetic alopecia. The Dublin-based biotech has plans to file with US and European regulators next year. Cosmo’s treatment, a 5% solution of clascoterone, delivered “statistically significant and clinically meaningful” improvements in target-area hair count (TAHC) versus placebo in two identically-designed Phase 3 studies. The drug produced a roughly five-fold relative improvement in hair count in one study, and an almost two-fold improvement in the other, the company said. The trials together enrolled more than 1,400 patients with male androgenetic alopecia (AGA) in the US and Europe, according to a company release . Clascoterone targets the sex hormone dihydrotestosterone directly at the hair follicle receptor, meaning there’s no systemic absorption or related safety risks, Cosmo said. The candidate was well tolerated in the Phase 3 studies, with a side-effect profile similar to placebo. This is important because current oral treatments for AGA involve systemic hormonal exposure, Cosmo said. This can lead to issues like decreased libido, erectile dysfunction and ejaculation problems. The biotech said it expects to complete a 12-month safety follow-up in spring 2026. CEO Giovanni Di Napoli described Wednesday’s results as “a pivotal moment for Cosmo and for billions of men worldwide who struggle every day with the emotional and social impact of hair loss.”

Phase 3Clinical Result

03 Dec 2025

·firstwordpharma.com

US, EU filings planned after Phase III wins for Cosmo's male pattern hair loss drug

Cosmo Pharmaceuticals plans regulatory submissions in both the US and Europe after reporting topline results from two successful Phase III trials of clascoterone 5% topical solution for male pattern hair baldness, news that sent company shares up 24% in Zurich on Wednesday.The studies — Scalp 1 and Scalp 2 — each met their primary endpoints, positioning Cosmo to move forward with the filings once the 12-month safety follow-up is completed in spring of 2026. Oddo BHF analysts estimate the potential market opportunity could reach several billion dollars.Clascoterone is a topical androgen-receptor inhibitor designed to block dihydrotestosterone directly at the hair-follicle receptor while minimising systemic hormonal exposure, a key limitation of currently available therapies. This localised mechanism "opens the door to a fundamentally better treatment paradigm for patients," CEO Giovanni Di Napoli said, noting that the company's internal market research suggests there is "enormous, underserved demand."The two identically designed trials enrolled a combined 1465 men in the US and Europe, making them the largest Phase III programme ever run for a topical therapy in male androgenetic alopecia, according to the company. In Scalp 1, clascoterone achieved a 539% relative improvement in Target-Area Hair Count (TAHC) versus vehicle, while Scalp 2 delivered a 168% relative improvement.Cosmo said these gains were reflected in patient-reported outcomes (PRO) as well. One trial met its PRO endpoint and the other trended positively; combined analysis across both studies was statistically significant, indicating participants not only grew more hair, but also perceived meaningful improvement.On the safety-front, Cosmo said rates of treatment-emergent adverse events were similar to vehicle in both studies, with most adverse events deemed unrelated to treatment.Clascoterone was approved by the FDA in 2020 as Winlevi to treat acne vulgaris in people aged 12 and older. Several companies are advancing alopecia treatments. AbbVie said in August that it was planning regulatory submissions for Rinvoq (upadacitinib) to treat hair loss after roughly 44% to 55% of patients on the JAK inhibitor achieved at least 80% scalp hair coverage (SALT score ≤20) at week 24 across a pair of Phase III studies.The hair-loss space has also drawn investor interest. Pelage Pharmaceuticals recently closed a $120-million series B round to advance a regenerative medicine approach that targets dormant stem cells in hair follicles, while Veradermics clinched a $150-million series C to fund ongoing Phase III studies evaluating its non-hormonal, oral treatment for hair loss in both men and women.

Phase 3Clinical ResultDrug ApprovalPhase 2

100 Deals associated with Cosmo Pharmaceuticals NV

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100 Translational Medicine associated with Cosmo Pharmaceuticals NV

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Pipeline

Pipeline Snapshot as of 12 Dec 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Early Phase 1

1

2

Phase 2

NDA/BLA

1

2

Approved

Other

13

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Clascoterone ( AR )	Acne Vulgaris More	NDA/BLA
Rifamycin Sodium ( rpoB )	Irritable bowel syndrome with diarrhea More	Phase 2
Colesevelam Hydrochloride ( FABP6 )	Diarrhea More	Phase 2
Parnaparin Sodium ( factor Xa )	Colitis, Ulcerative More	Phase 2
CB-03-10 ( AR x GR )	Advanced Malignant Solid Neoplasm More	Early Phase 1