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pp-107

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Progressive supranuclear palsy (PSP), a rare, rapidly progressing tau‑associated neurodegenerative disorder in adults Clinical stage: Phase 2 clinical development with topline recruitment completed Modality: Small molecule Mechanism / Target: Selective O‑GlcNAcase (OGA) enzyme inhibition to increase tau O‑GlcNAcylation and potentially reduce pathological tau aggregation Route / form: Oral administration (tablet) Differentiation: Brain‑penetrant OGA inhibitor targeting tau pathology with potential disease‑modifying effects in PSP where no approved therapies exist
Manufacturer #12186
The activity of the company is based on the development of highly competitive processes for the manufacture of active ingredients with high added value that meet the strictest quality specifications. They manufacture under strict compliance with the environmental and occupational safety regulations in force in Europe. They focus on the pharmaceutical, hospital, diagnostic, fine chemical, and food fields. Its products are marketed in more than 70 countries.

Manufacturer usually replies in 2 days

pp-036

Nebuliser solution

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Bronchiolitis obliterans syndrome, specifically in lung transplant patients, targeting a progressive rare inflammatory lung disease. Phase III; Inhaled liposomal formulation of cyclosporine A, delivering immunosuppression/anti-inflammatory action directly to the lung airways to halt fibrotic destruction of small airways. Unique inhaled immunosuppressive approach for BOS — no approved treatment for this indication currently.
Manufacturer #570

A pharmaceutical manufacturer based in the EU that has been active in 80+ countries selling its products for 110+ years. Main therapeutic areas include CNS, respiratory, and women’s health. Main dosage forms include sterile drugs, solid oral, and liquid forms. The company owns 20+ branches in Europe, North America, and Asia. The company possesses manufacturing facilities in Europe, Asia, and LATAM.

Manufacturer usually replies in 45 days

pp-248

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Switzerland
GMP approvals
EU GMP
Comments
Indication: Charcot-Marie-Tooth disease (CMT1, CMT2) / Clinical stage: Phase 2a SYNAPSE-CMT (80 patients) and Phase 2 SMA type 3 ongoing / Modality: Small molecule skeletal muscle ClC-1 chloride channel inhibitor / Mechanism & Target: CLC-1 channel inhibition amplifying neuromuscular transmission / Route & form: Oral, twice-daily dosing / Differentiation: First-in-class CLC-1 inhibitor; dual mechanism enhancing muscle excitability; FDA Orphan Drug Designation for CMT
Manufacturer #39447
Clinical-stage biotech focused on neuromuscular therapeutics targeting chloride ion channel modulation. Develops first-in-class inhibitors for rare inherited and acquired neuromuscular conditions. Advances Phase 2 programs across multiple neuromuscular disease indications.
 

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