A multi-center, single-arm, open-label study to evaluate tolerability, safety, and efficacy of topical MOB015B solution in the treatment of mild to moderate distal subungual onychomycosis (DSO) in subjects aged 6-17 years - N.A.

Start Date12 Jun 2023

Sponsor / Collaborator

Moberg Pharma AB

NCT05279846 / Active, not recruitingPhase 3

A Multi-center, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

This is a Phase 3 multicenter, double-blind study to evaluate the safety and efficacy of vehicle-controlled topical MOB015B in the treatment of Distal Subungual Onychomycosis (DSO)

Start Date09 May 2022

Sponsor / Collaborator

Moberg Pharma AB

NCT05135910 / Active, not recruitingPhase 2

An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis

The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).

Start Date13 Jan 2022

Sponsor / Collaborator

Hallux, Inc.

100 Clinical Results associated with Terbinafine Hydrochloride

100 Translational Medicine associated with Terbinafine Hydrochloride

100 Patents (Medical) associated with Terbinafine Hydrochloride

214

Literatures (Medical) associated with Terbinafine Hydrochloride

01 Nov 2023·Heliyon

Ternary cyclodextrin systems of terbinafine hydrochloride inclusion complexes: Solventless preparation, solid-state, and in vitro characterization

Article

Author: Kókai, Dávid ; Catenacci, Laura ; Csóka, Ildikó ; Sorrenti, Milena ; Burián, Katalin ; Ambrus, Rita ; Kondoros, Balázs Attila

Cyclodextrins (CD) are used extensively in the pharmaceutical industry to improve the water solubility and bioavailability of drugs. Preparing ternary systems by applying a third component can enhance these beneficial effects. The complexation methods of these ternary systems are the same as those of two-component complexes. These methods are solvent (co-evaporation, co-precipitation, etc.) or solventless "green" techniques (co-grinding, microwave irradiation, etc.). Using solvent-free methods is considered to be an economically and environmentally desirable technology. This study aimed to prepare ternary systems by the co-grinding method and evaluate the effect of a third component by comparing it to products obtained by solvent methods, binary systems, and marketed products. For that, we used terbinafine hydrochloride as a model drug, sulfobutyl-ether-beta-cyclodextrin as a complexation agent and 5 or 15 w/w% of polyvinylpyrrolidone K-90 (PVP) or hydroxypropyl methylcellulose (HPMC) as auxiliary components. Physicochemical evaluation (X-Ray Diffractometry, Differential Scanning Calorimetry, Thermogravimetry) showed that new solid phases were formed, while Scanning Electron Microscopy was performed to study morphological aspects of the products. Fourier transform infrared spectroscopic measurements suggested different intermolecular interactions depending on the type of polymer. In vitro dissolution studies showed beneficial effects of CD and further improvement with the applied polymers. Products showed less cell toxicity with one exception. Both polymers enhanced the physicochemical and in vitro properties, suggesting a greater bioavailability of the model drug. However, the percentage of polymers applied did not appear to be an influencing factor for these properties.

20 Oct 2023·Gels (Basel, Switzerland)

Thermo-Responsive Sol-Gel-Based Nano-Carriers Containing Terbinafine HCl: Formulation, In Vitro and Ex Vivo Characterization, and Antifungal Activity.

Article

Author: Irfan, Ali ; Bajwa, Maryam ; Jardan, Yousef A Bin ; Mehboob, Tooba ; Tabassam, Naila ; Zaman, Muhammad ; Riaz, Tehseen ; Hameed, Huma ; Khan, Mahtab Ahmad ; Shazly, Gamal A

The current research aims to create a sol-gel-based nanocarrier containing terbinafine formulated for transdermal delivery of the drug into the skin. Sol-gel-based nanocarriers were prepared via the cold method using poloxamer-188, poloxamer-407, and distilled water. The prepared formulation was examined for pH, gelation temperature, Fourier transform infrared spectrophotometer (FTIR) analysis, thermal stability analysis, X-ray diffraction (XRD), scanning electron microscopy (SEM), particle size analysis, zeta potential, and anti-microbial activity. The in-vitro drug release study of F1 was found to be 94%, which showed greater drug release as compared to F2 and F3. The pH of the formulation was found to be within the range applicable to the skin. The gelation temperature was detected at 28 °C. The SEM images of formulations have spotted various particles well-segregated from each other. Analysis of formulations showed a mean globule size diameter of 428 nm, zeta potential values of 0.04 mV, refractive index (1.329), and viscosity (5.94 cP). FTIR analysis confirmed various functional groups' presence in the prepared formulation. Thermal analysis has confirmed the stability of the drug within the prepared formulation. The growth of inhibition was found to be 79.2% in 60 min, which revealed that the prepared formulation has shown good permeation from the membrane. Hence, the sol-gel-based nanocarrier formulation of terbinafine was successfully developed and evaluated.

02 Oct 2023·AAPS PharmSciTech

Polymeric Nanocapsules Containing Ozonated Oil and Terbinafine Hydrochloride as a Potential Treatment Against Dermatophytes.

Article

Author: Contri, Renata Vidor ; Marques, Morgana Souza ; da Costa, Bárbara Souza ; Zilles, Júlia Capp ; Dos Santos, Francielli Lima ; Machado, Andressa Urbano ; Fuentefria, Alexandre Meneghello ; Kulkamp Guerreiro, Irene Clemes

Terbinafine hydrochloride is a synthetic allylamine whose mechanism of action consists of inhibiting the enzyme squalene epoxidase that participates in the first stage of ergosterol synthesis, interfering with fungal membrane function. Ozonated oils are used for topical application of ozone, producing reactive oxygen species that cause cellular damage in microorganisms, therefore being an alternative treatment for acute and chronic skin infections. This study aimed to develop and characterize Eudragit^® RS100 nanocapsules, obtained by interfacial deposition of preformed polymer method, containing 0.5% terbinafine hydrochloride and 5% ozonated sunflower seed oil as a potential treatment against dermatophytes. The polymeric nanocapsules were characterized regarding particle size, zeta potential, pH, drug content, encapsulation efficiency, and stability. The in vitro drug release, in vitro skin permeation, and in vitro antifungal activity were also evaluated. The particle size was around 150 nm with a narrow size distribution, the zeta potential was around + 6 mV, and the pH was 2.2. The drug content was close to 95% with an encapsulation efficiency of 53%. The nanocapsules were capable to control the drug release and the skin permeation. The in vitro susceptibility test showed greater antifungal activity for the developed nanocapsules, against all dermatophyte strains tested, compared to the drug solution. Therefore, the polymeric nanocapsules suspension containing terbinafine hydrochloride and ozonated oil can be considered a potential high-efficacy candidate for the treatment of dermatophytosis, with a possible reduction in the drug dose and frequency of applications. Studies to evaluate safety and efficacy in vivo still need to be performed.

News (Medical) associated with Terbinafine Hydrochloride

11 Jun 2024

·www.prnewswire.com

Moberg Pharma has secured exercise of warrants and entered into a top guarantee free of charge

STOCKHOLM, June 11, 2024 /PRNewswire/ -- Moberg Pharma AB (publ) ("Moberg Pharma" or the "Company") has today received subscription intentions, subscription commitments and top guarantee commitments totaling approximately SEK 113.5 million, related to the warrants of series 2023:1 ("TO 2"), from a few external professional investors and the Company's largest shareholder, Östersjöstiftelsen (The Baltic Sea Foundation). "When we designed the rights issue of units last summer, the goal was to raise approximately SEK 200 million, half of which through the TO 2 warrants. The subscription commitments and the top guarantee mean that the company has now secured this capital free of charge. Any additional capital raised through the TO 2 warrants is expected to promote growth and shareholder value. TO 2 has also provided an opportunity to further strengthen our shareholder base, in addition to the continued support from our main shareholder Östersjöstiftelsen. We are pleased to have secured the financing and look forward to dedicating our time to executing our launch plans for the drug MOB-015, which has recently been approved in 13 EU countries and where our partner Allderma has taken the product to a market-leading position in Sweden under the brand name Terclara®.", says Anna Ljung, CEO of Moberg Pharma. In total, there are 18,134,519 TO 2, whereby each TO 2 entitles the holder to subscribe for one (1) new ordinary share in the Company at a subscription price of SEK 18.00 during the period from and including June 5th, 2024, up to and including June 19th, 2024. The outcome of the exercise of TO 2 will be announced through a press release on or about June 24th, 2024. In the event that all TO 2 are exercised for subscription of ordinary shares, Moberg Pharma will receive approximately SEK 326.4 million before issue costs. Östersjöstiftelsen, the Company's largest shareholder, has announced its intention to exercise 1,388,888 TO 2 for subscription of ordinary shares, corresponding to approximately SEK 25.0 million. Furthermore, the Company has also entered into subscription and top guarantee commitments, free of charge, with few external professional investors; Special Situations Fund, Fredrik Lundgren and Wilhelm Risberg. Special Situations Fund is a US institutional investor based in New York. In total, the subscription commitments amount to approximately SEK 10.8 million and the top guarantee commitments amount to SEK 77.7 million. The top guarantee commitments are intended to be utilized to at least 20 percent, corresponding to approximately SEK 15.5 million, and successively more in the event that the utilization of TO 2 is less than 17,271,186 ordinary shares. Subscription of ordinary shares under the top guarantee commitments will in practice be made through subscription in a directed share issue, resolved by the Board of Directors based on the authorization from the Annual General Meeting on May 14th,2024, after the exercise period for TO 2 has ended (the " Share Issue"). Subscription in the Share Issue will be made at the same subscription price as for TO 2, i.e. SEK 18.00 per ordinary share. The investors who have entered into top guarantee commitments, Special Situations Fund, Fredrik Lundgren and Wilhelm Risberg, are guaranteed allotment of ordinary shares corresponding to at least 20 percent of their respective guarantee commitments. The subscription and top guarantee commitments are not secured by way of a first priority transaction, bank guarantee, pledge or similar. The Board of Directors has carefully considered the possibility of raising capital through a rights issue and makes the assessment that it is currently for several reasons more advantageous for the Moberg Pharma and the shareholders to raise capital by ensuring the exercise of TO 2 and to carry out the Share Issue. The investors who have entered into top guarantee commitments, and thus will participate in the Share Issue, are guaranteed allotment of ordinary shares corresponding to at least 20 percent of their respective guarantee commitments. Thus, the size of the Share Issue is dependent on the warrant holders exercise of TO 2. Warrant holders are free to exercise TO 2 and thereby limit the size of the Share Issue. The Company also believes that a rights issue under the current volatile market conditions would entail higher costs related to any underwriting. Finally, the Company wishes to expand and strengthen its base of institutional and professional shareholders to, among other things, improve the liquidity of the Company's share. In light of this, the Board of Directors' overall assessment is that the reasons for ensuring the exercise of TO 2 and to carry out the Share Issue with deviation from the shareholders' preferential rights clearly and with sufficient strength outweigh the reasons that justify the main rule that new issues shall be carried out with the shareholders preferential rights. The subscription price in the Share Issue has been determined in consultation with the Company's financial advisor, Vator Securities AB, through arm's length negotiations with a number of institutional and professional investors over time. Therefore, the Board of Directors of the Company considers that the subscription price has been determined on market terms and correctly reflects current market conditions and demand. The Board of Directors intends, based on the authorization from the Annual General Meeting on May 14th, 2024, to resolve on the Share Issue on or around June 24th, 2024, i.e. after the outcome of the exercise of TO 2 has been announced. Upon full exercise of all 18,134,519 TO 2, the Company's share capital will increase by approximately SEK 18,134,519.90. Through the Share Issue, the share capital may increase by a maximum of approximately SEK 4,316,666.22 by issuing a maximum of 4,136,666 new ordinary shares, which corresponds to a dilution effect of approximately 12.9 percent. Upon full exercise of all TO 2 and the Share Issue, the number of shares will increase by a maximum of 18,997,852. Advisors Vator Securities is acting as financial advisor and Advokatfirman Schjødt is legal advisor to Moberg Pharma in connection with the transaction. About this information This information is information that Moberg Pharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 7.30 a.m. CEST on June 11th, 2024. For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: [email protected] Mark Beveridge, Vice President Finance, telephone: +46 76 805 82 88, e-mail: [email protected] About Moberg Pharma, Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The Company's asset, MOB-015, is a novel topical treatment for onychomycosis with market approval in 13 EU countries. MOB-015 is available in Sweden under the brand name Terclara®. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the Company's shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB). Important information The information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Moberg Pharma. The invitation to the persons concerned to subscribe for units consisting of shares and warrants in Moberg Pharma has only been made through the prospectus published by Moberg Pharma on August 14th, 2023. This information was brought to you by Cision The following files are available for download: SOURCE Moberg Pharma

Phase 3Drug Approval

11 Jun 2024

·www.biospace.com

Moberg Pharma has secured exercise of warrants and entered into a top guarantee free of charge - June 11, 2024

STOCKHOLM, June 11, 2024 /PRNewswire/ -- Moberg Pharma AB (publ) ("Moberg Pharma" or the "Company") has today received subscription intentions, subscription commitments and top guarantee commitments totaling approximately SEK 113.5 million, related to the warrants of series 2023:1 ("TO 2"), from a few external professional investors and the Company's largest shareholder, Östersjöstiftelsen (The Baltic Sea Foundation). "When we designed the rights issue of units last summer, the goal was to raise approximately SEK 200 million, half of which through the TO 2 warrants. The subscription commitments and the top guarantee mean that the company has now secured this capital free of charge. Any additional capital raised through the TO 2 warrants is expected to promote growth and shareholder value. TO 2 has also provided an opportunity to further strengthen our shareholder base, in addition to the continued support from our main shareholder Östersjöstiftelsen. We are pleased to have secured the financing and look forward to dedicating our time to executing our launch plans for the drug MOB-015, which has recently been approved in 13 EU countries and where our partner Allderma has taken the product to a market-leading position in Sweden under the brand name Terclara®.", says Anna Ljung, CEO of Moberg Pharma. In total, there are 18,134,519 TO 2, whereby each TO 2 entitles the holder to subscribe for one (1) new ordinary share in the Company at a subscription price of SEK 18.00 during the period from and including June 5th, 2024, up to and including June 19th, 2024. The outcome of the exercise of TO 2 will be announced through a press release on or about June 24th, 2024. In the event that all TO 2 are exercised for subscription of ordinary shares, Moberg Pharma will receive approximately SEK 326.4 million before issue costs. Östersjöstiftelsen, the Company's largest shareholder, has announced its intention to exercise 1,388,888 TO 2 for subscription of ordinary shares, corresponding to approximately SEK 25.0 million. Furthermore, the Company has also entered into subscription and top guarantee commitments, free of charge, with few external professional investors; Special Situations Fund, Fredrik Lundgren and Wilhelm Risberg. Special Situations Fund is a US institutional investor based in New York. In total, the subscription commitments amount to approximately SEK 10.8 million and the top guarantee commitments amount to SEK 77.7 million. The top guarantee commitments are intended to be utilized to at least 20 percent, corresponding to approximately SEK 15.5 million, and successively more in the event that the utilization of TO 2 is less than 17,271,186 ordinary shares. Subscription of ordinary shares under the top guarantee commitments will in practice be made through subscription in a directed share issue, resolved by the Board of Directors based on the authorization from the Annual General Meeting on May 14th,2024, after the exercise period for TO 2 has ended (the "Share Issue"). Subscription in the Share Issue will be made at the same subscription price as for TO 2, i.e. SEK 18.00 per ordinary share. The investors who have entered into top guarantee commitments, Special Situations Fund, Fredrik Lundgren and Wilhelm Risberg, are guaranteed allotment of ordinary shares corresponding to at least 20 percent of their respective guarantee commitments. The subscription and top guarantee commitments are not secured by way of a first priority transaction, bank guarantee, pledge or similar. The Board of Directors has carefully considered the possibility of raising capital through a rights issue and makes the assessment that it is currently for several reasons more advantageous for the Moberg Pharma and the shareholders to raise capital by ensuring the exercise of TO 2 and to carry out the Share Issue. The investors who have entered into top guarantee commitments, and thus will participate in the Share Issue, are guaranteed allotment of ordinary shares corresponding to at least 20 percent of their respective guarantee commitments. Thus, the size of the Share Issue is dependent on the warrant holders exercise of TO 2. Warrant holders are free to exercise TO 2 and thereby limit the size of the Share Issue. The Company also believes that a rights issue under the current volatile market conditions would entail higher costs related to any underwriting. Finally, the Company wishes to expand and strengthen its base of institutional and professional shareholders to, among other things, improve the liquidity of the Company's share. In light of this, the Board of Directors' overall assessment is that the reasons for ensuring the exercise of TO 2 and to carry out the Share Issue with deviation from the shareholders' preferential rights clearly and with sufficient strength outweigh the reasons that justify the main rule that new issues shall be carried out with the shareholders preferential rights. The subscription price in the Share Issue has been determined in consultation with the Company's financial advisor, Vator Securities AB, through arm's length negotiations with a number of institutional and professional investors over time. Therefore, the Board of Directors of the Company considers that the subscription price has been determined on market terms and correctly reflects current market conditions and demand. The Board of Directors intends, based on the authorization from the Annual General Meeting on May 14th, 2024, to resolve on the Share Issue on or around June 24th, 2024, i.e. after the outcome of the exercise of TO 2 has been announced. Upon full exercise of all 18,134,519 TO 2, the Company's share capital will increase by approximately SEK 18,134,519.90. Through the Share Issue, the share capital may increase by a maximum of approximately SEK 4,316,666.22 by issuing a maximum of 4,136,666 new ordinary shares, which corresponds to a dilution effect of approximately 12.9 percent. Upon full exercise of all TO 2 and the Share Issue, the number of shares will increase by a maximum of 18,997,852. Advisors Vator Securities is acting as financial advisor and Advokatfirman Schjødt is legal advisor to Moberg Pharma in connection with the transaction. About this information This information is information that Moberg Pharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 7.30 a.m. CEST on June 11th, 2024. For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se Mark Beveridge, Vice President Finance, telephone: +46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se About Moberg Pharma, Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The Company's asset, MOB-015, is a novel topical treatment for onychomycosis with market approval in 13 EU countries. MOB-015 is available in Sweden under the brand name Terclara®. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the Company's shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB). Important information The information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Moberg Pharma. The invitation to the persons concerned to subscribe for units consisting of shares and warrants in Moberg Pharma has only been made through the prospectus published by Moberg Pharma on August 14th, 2023. This information was brought to you by Cision The following files are available for download: View original content: SOURCE Moberg Pharma Company Codes: Bloomberg:MOB@SS, ISIN:SE0013121340, RICS:MOB.ST, Stockholm:MOB

Phase 3Drug Approval

07 Feb 2024

·www.prnewswire.com

MOB-015 is launched in Sweden under the brand name Terclara- pharmacies report major demand for the new medication

STOCKHOLM, Feb. 7, 2024 /PRNewswire/ -- Moberg Pharma ABs (OMX: MOB) marker partner in Sweden - Allderma AB, a company which specialises in the sale of over-the-counter (OTC) pharmaceuticals - has now launched sales of MOB-015 under the Terclara® brand. The interest among pharmacies has been significant for Moberg Pharma's medication against nail fungus. " t is incredibly rewarding to work with such a committed market partner as Allderma", says Anna Ljung, CEO of Moberg Pharma, and continues:" The introduction of Terclara® to Swedish pharmacy chains has gone very well. Allderma's approach and good results demonstrate why they are an excellent partner in our home market." Allderma is managed by the commercial leaders which were responsible for the successful Nordic launch of Nalox®, Moberg Pharma's first-generation nail fungus product. "We have high expectations for the launch of MOB-015 - the first topical medication with an equivalent antifungal effect to tablets but without the risk of serious side effects. The goal is the same as last time, to achieve a market-leading position", says Mimmi Frölén, CEO of Allderma AB. Currently, the majority of pharmacies throughout Sweden have decided to start selling Terclara®. For additional information, please contact: Anna Ljung, CEO, telephone: +46 707 66 60 30, E-mail: [email protected] Anders Bröijersén, Chief Medical Officer, telephone: +46 760 01 15 76, E-mail: [email protected] About this information This information was submitted for publication, through the agency of the contact persons set out above, on February 7th, 2024, at 8.00 am CEST. About MOB-015 and Onychomycosis Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than hundred million patients worldwide and a clear demand for better products. Moberg Pharma estimates the annual worldwide peak sales potential for MOB-015 to be in the range of USD 250-500 million. MOB-015 is an in-house developed topical formulation of terbinafine, enabling effective concentrations of terbinafine to the nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. MOB-015 is recommended for national approval in 13 European countries and is launched in Sweden under the brand name Terclara®. The approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators), and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions. About Moberg Pharma, Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The Company's asset, MOB-015, is a novel topical treatment for onychomycosis, for which market approvals in several EU-countries has recently been obtained. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the Company's shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB). About Allderma Pharmaceuticals, Allderma Pharmaceuticals is a Swedish pharmaceutical company that since 2001 develops, sells and markets over the counter and self-care products. The range spans a number of different treatment areas, with a focus and expertise in dermatology. Founder Hans Svartholm started Allderma after working in the pharmaceutical industry for many years. The idea was simple and still applies it should be easy to find an effective and safe product for the most common skin problems. Allderma emphasis and invests in information for healthcare providers, pharmacists, doctors and consumers. Product specialists work continuously to be a spear head in research and innovation within dermatology. Allderma has been part of 3iM Invest AB's investment area Consumer Healthcare since 2020. The following files are available for download:

Phase 3Clinical ResultDrug Approval

100 Deals associated with Terbinafine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02219	Terbinafine Hydrochloride	D01AE15 D01BA02	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Tinea corporis	AU	Novartis Pharmaceuticals Australia Pty Ltd.	22 Dec 2003
tinea cruris	AU	Novartis Pharmaceuticals Australia Pty Ltd.	22 Dec 2003
Tinea Pedis	US	GlaxoSmithKline Consumer Healthcare Ltd.	09 Mar 1999
Dermatomycoses	CN	Qilu Pharmaceutical Co., Ltd.	01 Jan 1997
Candidiasis, Cutaneous	JP	Sun Pharmaceutical Industries Ltd.	02 Jul 1993
Tinea Versicolor	JP	Sun Pharmaceutical Industries Ltd.	02 Jul 1993
Tinea Capitis	US	Novartis Pharmaceuticals Corp.	30 Dec 1992
Mycoses	GB	Novartis Pharmaceuticals UK Ltd.	03 Oct 1990
Onychomycosis	GB	Novartis Pharmaceuticals UK Ltd.	03 Oct 1990
Tinea	GB	Novartis Pharmaceuticals UK Ltd.	03 Oct 1990

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Erythema	Phase 1	US	Moberg Pharma AB	15 Oct 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02859519 (Pubmed \| J Am Acad Dermatol) Manual	Phase 3	Onychomycosis	-	MOB-015	rciqzdnbsn(qrjebfiule) = mupqarjucn drgopegmjm (nwthlxkpqi ) View more	Non-superior	01 Jul 2021
				vehicle	rciqzdnbsn(qrjebfiule) = jcvsaekkcj drgopegmjm (nwthlxkpqi ) View more
Corporate Publications Manual	Phase 3	Onychomycosis	452	Terbinafine Hydrochloride	jkfnskehif(psmupxsuzj) = ghtnhhsnye fnaiwgwmpt (okopunvyhc ) View more	Non-inferior	25 Jun 2020
				ciclopirox	jkfnskehif(psmupxsuzj) = xvsgbstjhe fnaiwgwmpt (okopunvyhc ) View more

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