Delving into the Latest Updates on Udonitrectag lysine with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

Negermin lysine salt, Udonitrectag, Udonitrectag lysine salt

+ [4]

Target

p75NTR

Action

agonists

Mechanism

p75NTR agonists(Low affinity neurotrophin receptor p75NTR agonists)

Therapeutic Areas

Eye DiseasesOther DiseasesNervous System Diseases+ [5]

Active Indication

Neurotrophic keratitisDiabetic foot ulcerAnemia, Sickle Cell+ [5]

Inactive Indication-

Originator Organization

MimeTech SRL

Active Organization

MimeTech SRL

Inactive Organization

Recordati Rare Diseases, Inc.

License Organization

MimeTech SRL

Recordati SpA

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States), Orphan Drug (European Union), PRIME (European Union)

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Structure/Sequence

Molecular FormulaC20H19NO5

InChIKeySEKGLVUAECPQQM-NHAYFPRASA-N

CAS Registry1458063-04-1

Chalcones and Mannich bases are a group of compounds known for their cytotoxicities. In this study restricted chalcone analogue, compound 2-(4-hydroxybenzylidene)-2,3-dihydroinden-1-one MT1, was used as a starting compound to synthesize new mono Mannich bases since Mannich bases may induce more cytotoxicity than chalcone analogue that they are derived from by producing additional alkylating center for cellular thiols. In this study, cyclic and acyclic amines were used to synthesize Mannich bases. All compounds were tested against Ca9-22 (gingival carcinoma), HSC-2, HSC-3 and HSC-4 (oral squamous cell carcinoma) as tumour cell lines and HGF (gingival fibroblasts), HPC (pulp cells) and HPLF (periodontal ligament fibroblasts) human normal oral cells as non tumour cell lines. Cytotoxicity, selectivity index (SI) values and potency selectivity expression (PSE) values expressed as a percentage were determined for the compounds. According to data obtained, the compound MT8 with the highest PSE value bearing N-methylpiperazine moiety seems to be a good candidate to develop new cytotoxic compounds and is suited for further investigation.

Pharmaceutics

Novel Transethosomal Gel Containing Miconazole Nitrate; Development, Characterization, and Enhanced Antifungal Activity

Article

Author: Gad, Heba A. ; Sajid-ur-Rehman, Muhammad ; Asghar, Zara ; Jamshaid, Usama ; Jamshaid, Talha

Miconazole nitrate (MCNR) is a BCS class II antifungal drug with poor water solubility. Although numerous attempts have been made to increase its solubility, formulation researchers struggle with this significant issue. Transethosomes are promising novel nanocarriers for improving the solubility and penetration of drugs that are inadequately soluble and permeable. Thus, the objective of this study was to develop MCNR-loaded transethosomal gel in order to enhance skin permeation and antifungal activity. MCNR-loaded transethosomes (MCNR-TEs) were generated using the thin film hydration method and evaluated for their zeta potential, particle size, polydispersity index, and entrapment efficiency (EE%). SEM, FTIR, and DSC analyses were also done to characterize the optimized formulation of MCNR-TEs (MT-8). The optimized formulation of MCNR-TEs was incorporated into a carbopol 934 gel base to form transethosomal gel (MNTG) that was subjected to ex vivo permeation and drug release studies. In vitro antifungal activity was carried out against Candida albicans through the cup plate technique. An in vivo skin irritation test was also performed on Wistar albino rats. MT-8 displayed smooth spherical transethosomal nanoparticles with the highest EE% (89.93 ± 1.32%), lowest particle size (139.3 ± 1.14 nm), polydispersity index (0.188 ± 0.05), and zeta potential (−18.1 ± 0.10 mV). The release profile of MT-8 displayed an initial burst followed by sustained release, and the release data were best fitted with the Korsmeyer-Peppas model. MCNR-loaded transethosomal gel was stable and showed a non-Newtonian flow. It was found that ex vivo drug permeation of MNTG was 48.76%, which was significantly higher than that of MNPG (plain gel) (p ≤ 0.05) following a 24-h permeation study. The prepared MCNR transethosomal gel exhibited increased antifungal activity, and its safety was proven by the results of an in vivo skin irritation test. Therefore, the developed transethosomal gel can be a proficient drug delivery system via a topical route with enhanced antifungal activity and skin permeability.

5

News (Medical) associated with Udonitrectag lysine

29 Oct 2025

·mimetech.eu

EMA Grants PRIME Designation to MimeTech S.r.l. for Investigational Drug Udonitrectag Lysine in the Treatment of Diabetic Foot Ulcers (DFU)

We are proud to announce that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to our investigational drug, Udonitrectag lysine, for the treatment of diabetic foot ulcers (DFU). Existing measures for the treatment of diabetic foot ulcers achieve complete healing in only 30–60% of cases within six months, with 40% one-year recurrence and amputation rates around 20–30% in complicated ulcers. This represents a significant unmet medical need for innovative medicines capable of providing a clinically meaningful and durable improvement in healing and limb salvage. Evidence from a 6-week, randomised, single-blind, comparative Phase 1/2 study in 24 patients with slow-healing diabetic foot ulcers testing Udonitrectag lysine in addition to standard of care versus standard of care alone suggests that a potentially clinically meaningful treatment effect addressing this unmet medical need can be achieved. PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary programme is based on enhanced interaction and early dialogue with developers of promising medicines to optimise development plans and accelerate evaluation, helping these medicines reach patients earlier. “Receiving PRIME designation is an important recognition of the potential of Udonitrectag lysine to make a real difference for patients affected by diabetic foot ulcers,” said Federico Cozzolino, CEO of MimeTech S.r.l. “We look forward to working closely with EMA to advance the development of this innovative therapy and to bring it as soon as possible to patients in need.”

27 Jan 2022

·mimetech.eu

“Udonitrectag” receives orphan drug designation from the European Commission as treatment in solid organ transplantation

On 15/11/2021, orphan designation (EU/3/21/2521) was granted by the European Commission to MIMETECH S.r.l., Italy, for Udonitrectag as treatment in solid organ transplantation. When organs are transplanted, the period in which they are cut off from their normal blood supply can lead to damage and death of cells that means they work less well after transplantation and are prone to inflammation that increases the risk of rejection. The medicine acts in the same way as natural growth factors that help to protect cells from this type of damage. This is expected to improve the function of the transplanted organ and reduce the risk of rejection. At the time of submission of the application for orphan designation the effects of the medicine had been evaluated in experimental models and no clinical trials in patients undergoing solid organ transplantation had been started.

Orphan Drug

05 Dec 2018

·mimetech.eu

Recordati receives Orphan Drug Designation for its investigational treatment for neurotrophic keratitis

Recordati today announced that the FDA has granted Orphan Drug Designation to Recordati Rare Disease’s investigational product REC 0559 for the treatment of neurotrophic keratitis. REC 0559 is a low molecular weight non-peptidic human nerve growth factor (NGF) mimetic currently under global development by Recordati. REC 0559 was licensed in 2017 from MimeTech, an Italian based company focused on the development of pharmaceutical applications for synthetic neurotrophin mimetics. Neurotrophic keratitis is a rare degenerative corneal disease, which in its more severe forms affects less than one person out of 10,000 worldwide, and it results from a deficiency of the trigeminal nerve or its branches, usually caused by surgery, neoplasia, aneurysm or facial trauma. Impairment or loss of corneal sensory innervation is responsible for corneal epithelial defects, ulcer, and perforation, with a progression of the disease leading to dramatic impairment to patients’ sight. Orphan drug designation applies to drugs that seek to treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. while providing a significant therapeutic advantage over existing therapies. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and an exemption from FDA user fees. “Orphan drug designation is a key regulatory achievement in the global development of REC 0559. We are very pleased to receive the designation from US FDA, which confirms our continuous commitment to innovative treatments to address the needs of patients suffering from rare diseases”, stated Andrea Recordati, CEO. “This represents another significant step in the development of our business dedicated to the treatment of diseases with unmet medical needs.”

Orphan Drug

100 Deals associated with Udonitrectag lysine

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Keratitis	Phase 2	United States	Recordati Rare Diseases, Inc.	13 Oct 2020
Keratitis	Phase 2	France	Recordati Rare Diseases, Inc.	13 Oct 2020
Keratitis	Phase 2	Germany	Recordati Rare Diseases, Inc.	13 Oct 2020
Keratitis	Phase 2	Hungary	Recordati Rare Diseases, Inc.	13 Oct 2020
Keratitis	Phase 2	Italy	Recordati Rare Diseases, Inc.	13 Oct 2020
Keratitis	Phase 2	Spain	Recordati Rare Diseases, Inc.	13 Oct 2020
Keratitis	Phase 2	United Kingdom	Recordati Rare Diseases, Inc.	13 Oct 2020
Diabetic foot ulcer	Phase 2	-	MimeTech SRL	-
Neurotrophic keratitis	Phase 2	-	MimeTech SRL	-
Anemia, Sickle Cell	IND Application	-	MimeTech SRL	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04276558 (CTgov)	Phase 2	Neurotrophic keratitis	108	Vehicle+Udonitrectag (Dose 1 - 0.5 µg/Day)	jjvsipojoe = czljrquvmd lnqkbibcae (vszkbnidtt, fjzfgqxkhr - zlxmzbbsmf) View more	-	14 May 2025
				Vehicle+Udonitrectag (Dose 2 - 2.5 µg/Day)	jjvsipojoe = ocidbukprf lnqkbibcae (vszkbnidtt, prhqgsccrj - evckeycakt) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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