Delving into the Latest Updates on Sarecycline Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Sarecycline hydrochloride (USAN)

+ [5]

Target

30S subunit

Action

inhibitors

Mechanism

30S subunit inhibitors(30S ribosomal subunit inhibitors)

Therapeutic Areas

Skin and Musculoskeletal Diseases

Active Indication

Acne Vulgaris

Inactive Indication-

Originator Organization

Paratek Pharmaceuticals, Inc.

Active Organization

Almirall LLCPackaging Coordinators Holdings LLC

Penn Pharmaceutical Services Ltd.

+ [1]

Inactive Organization

Paratek Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (01 Oct 2018),

Acne Vulgaris

Regulation-

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Structure/Sequence

Molecular FormulaC24H30ClN3O8

InChIKeyAPPRLAGZQKOUFL-FIPJBXKNSA-N

CAS Registry1035979-44-2

View All Structures (2)

The antibacterial activity of Sarecycline against clinical strains of the main acne-related pathogens (Propionibacterium acnes, Staphylococcus epidermidis, and Staphylococcus aureus) was studied by culturing, isolating, and identifying the main acne-related pathogens (Propionibacterium acnes, Staphylococcus epidermidis, and Staphylococcus aureus) from the lesions of patients with acne vulgaris

Start Date12 Oct 2022

Sponsor / Collaborator

Almirall LLC

[+3]

100 Clinical Results associated with Sarecycline Hydrochloride

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100 Translational Medicine associated with Sarecycline Hydrochloride

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100 Patents (Medical) associated with Sarecycline Hydrochloride

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88

Literatures (Medical) associated with Sarecycline Hydrochloride

01 Jan 2025·Dermatologic Clinics

Innovations in Acne

Review

Author: Barbieri, John S ; Barbieri, John S. ; Wafae, Bruna Galvao de Oliveira

Although many treatments are available for acne, these can be limited by lack of effectiveness, patient tolerance and adherence, and accessibility. This review provides a comprehensive summary of the latest developments in acne management, exploring a range of topical, systemic, and procedural treatments. The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed.

01 Sep 2024·Luminescence

P‐doped carbon dot nano‐probe for inner filter effect–based determination of sarecycline in pharmaceutical dosage form and human plasma

Article

Author: Yassin, Mohamed G. ; Elshenawy, Eman A. ; Marie, Aya A.

AbstractBased on novel phosphorus‐doped carbon dots (PCDs), a simple, quick, and accurate fluorescence probe for sarecycline (SAR) determination has been created. The PCDs were prepared in just five minutes using green, straightforward one‐step microwave pyrolysis. To create the PCD probe, sodium phosphate monobasic was utilized as a phosphorus dopant and citric acid as a carbon supply. The proposed synthesis method was energy efficient and yielded CDs with a narrow particle size distribution. Based on inner‐filter effect mechanism, the generated PCDs were used as nano‐probe for SAR determination. The fluorescence quenching intensity showed a strong linear relationship with SAR concentration in the 3–90‐μM range with a detection limit of 0.88 μM. Because there is no surface alteration of the CDs or creation of a covalent bond between SAR and PCDs, the developed approach is quick, easy, inexpensive, and requires less time. The new probe's enhanced sensitivity, broad linear range, and acceptable selectivity made it suitable for SAR measurement in pharmaceutical formulations and spiked human plasma. Most importantly, the Green Analytical Procedure Index (GAPI) and Analytical GREEnness (AGREE) assessments showed that the suggested method was environmentally friendly.

01 Sep 2024·Journal of drugs in dermatology : JDD

To Acne and Beyond: A Review of Sarecycline's Off-Label Uses.

Review

Author: Menta, Nikita ; Vidal, Savanna I ; Friedman, Adam

64

News (Medical) associated with Sarecycline Hydrochloride

05 Mar 2024

·www.globenewswire.com

Paratek Pharmaceuticals Announces Positive Efficacy Data for NUZYRA® as Post-Exposure Prophylaxis of Inhalational Anthrax, Triggering Additional Procurement under BARDA Project BioShield Contract

Oral NUZYRA Tablets Procured by BARDA were Manufactured in the United States as Part of the Company’s Onshoring InitiativeBOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, today announced positive top-line efficacy data for NUZYRA® (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death. In the study, a 100% survival rate was observed in omadacycline-treated NHPs at the end of the treatment period (30 days) and a survival rate over 90% was observed over the entirety of the 60-day observation period. All NHPs treated with placebo died due to anthrax within 10 days of exposure to B. anthracis. Top-line data from this study triggered an additional procurement of NUZYRA under the company’s Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts. “Positive top-line data from this study represents continued progress in our anthrax development program and further validates NUZYRA’s potential to effectively treat pulmonary anthrax,” said Randy Brenner, Paratek’s chief development and regulatory officer. “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil. We are grateful for BARDA’s continued commitment in our partnership to address national security threats and public health emergencies involving anthrax, and believe that these efforts further strengthen our nation’s commitment to address potential bioterrorism threats at a time when antibiotic resistance is a global concern.” A meeting with FDA will be planned for the middle of 2024 to align on the final studies required to support the sNDA submission for both anthrax treatment and PEP indications. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for Seysara® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and X. About NUZYRA®NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. MEDIA CONTACT:Christine FanelleScient PRChristine@ScientPR.com215-595-5211

License out/inPhase 2Clinical ResultDrug Approval

19 Feb 2024

·www.biospace.com

Novo Licenses to Almirall Potential First-in-Class Antibody Candidate

Novo Nordisk’s corporate headquarters in Denmark iStock, Ole Schwander Almirall will have exclusive global rights to develop and commercialize the anti-IL-21 monoclonal antibody NN-8828 in several fields, including immune inflammatory dermatological indications. Pictured: Novo Nordisk’s corporate headquarters in Denmark/iStock, Ole Schwander Spanish pharma Almirall announced Monday that it has licensed Novo Nordisk ’s anti-IL-21 monoclonal antibody NN-8828, which it plans to develop as a treatment for immune inflammatory dermatological diseases and has first-in-class potential. Almirall is looking to “accelerate the development” of NN-8828 with an eye towards eventually debuting the candidate on the global market for “key dermatological diseases,” according to Monday’s announcement. Under the licensing agreement, Novo will receive an undisclosed upfront payment and will be entitled to developmental and commercial milestones, as well as tiered royalties on future global sales. The licensing agreement will allow Almirall to “explore the innovative approach of IL-21 blockage as a possible new pathway to effectively treat a range of dermatological diseases,” CSO Karl Ziegelbauer said in a statement. The pharma, headquartered in Barcelona, Spain, is focused on medical dermatology. NN-8828 is a monoclonal antibody that targets and binds the IL-21 cytokine with high affinity. IL-21 is a key player in the inflammatory cascade and has been implicated in various immune-based skin diseases , including atopic dermatitis, psoriasis, pemphigus and Sjögren’s syndrome. By blocking IL-21 signaling, NN-8828 can potentially inhibit the underlying mechanisms of these diseases providing “a promising option for the treatment of inflammatory and autoimmune skin disorders,” according to Almirall. Before punting the candidate over to Almirall, Novo had trialed NN-8828 up to Phase II in non-dermatological conditions. In January 2013, the Danish pharma announced that it was discontinuing the development of NN-8828 in rheumatoid arthritis after the candidate delivered a middling performance in a Phase IIa study. NN-8828 met its primary endpoint of significantly lowering disease activity versus placebo but “the magnitude of the treatment effect did not warrant further development,” according to Novo. The Danish drugmaker continued assessing NN-8828 in other inflammatory diseases, such as Crohn’s disease and systemic lupus erythematosus, but ultimately exited the inflammation space entirely in September 2014. Now part of Almirall’s holdings, NN-8828 joins a pipeline of promising dermatology therapies anchored by lebrikizumab, which is currently undergoing regulatory review in the European Union for the treatment of atopic dermatitis. Almirall licensed the European rights for lebrikizumab from Dermira in June 2019. Eli Lilly acquired Dermira in January 2020 . Also under review in the EU is Almirall’s efinaconazole, an investigational treatment for the fungal infection onychomycosis and sarecycline, meant to treat acne. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .

License out/inPhase 2AcquisitionPhase 1Clinical Result

19 Feb 2024

·www.biospace.com

Novo Licenses to Almirall Potential First-in-Class Antibody Candidate

Pictured: Novo Nordisk's corporate headquarters in Denmark/iStock, Ole Schwander Spanish pharma Almirall announced Monday that it has licensed Novo Nordisk’s anti-IL-21 monoclonal antibody NN-8828, which it plans to develop as a treatment for immune inflammatory dermatological diseases and has first-in-class potential. Almirall is looking to “accelerate the development” of NN-8828 with an eye towards eventually debuting the candidate on the global market for “key dermatological diseases,” according to Monday’s announcement. Under the licensing agreement, Novo will receive an undisclosed upfront payment and will be entitled to developmental and commercial milestones, as well as tiered royalties on future global sales. The licensing agreement will allow Almirall to “explore the innovative approach of IL-21 blockage as a possible new pathway to effectively treat a range of dermatological diseases,” CSO Karl Ziegelbauer said in a statement. The pharma, headquartered in Barcelona, Spain, is focused on medical dermatology. NN-8828 is a monoclonal antibody that targets and binds the IL-21 cytokine with high affinity. IL-21 is a key player in the inflammatory cascade and has been implicated in various immune-based skin diseases, including atopic dermatitis, psoriasis, pemphigus and Sjögren's syndrome. By blocking IL-21 signaling, NN-8828 can potentially inhibit the underlying mechanisms of these diseases providing “a promising option for the treatment of inflammatory and autoimmune skin disorders,” according to Almirall. Before punting the candidate over to Almirall, Novo had trialed NN-8828 up to Phase II in non-dermatological conditions. In January 2013, the Danish pharma announced that it was discontinuing the development of NN-8828 in rheumatoid arthritis after the candidate delivered a middling performance in a Phase IIa study. NN-8828 met its primary endpoint of significantly lowering disease activity versus placebo but “the magnitude of the treatment effect did not warrant further development,” according to Novo. The Danish drugmaker continued assessing NN-8828 in other inflammatory diseases, such as Crohn’s disease and systemic lupus erythematosus, but ultimately exited the inflammation space entirely in September 2014. Now part of Almirall’s holdings, NN-8828 joins a pipeline of promising dermatology therapies anchored by lebrikizumab, which is currently undergoing regulatory review in the European Union for the treatment of atopic dermatitis. Almirall licensed the European rights for lebrikizumab from Dermira in June 2019. Eli Lilly acquired Dermira in January 2020. Also under review in the EU is Almirall’s efinaconazole, an investigational treatment for the fungal infection onychomycosis and sarecycline, meant to treat acne. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

License out/inPhase 2AcquisitionPhase 1Clinical Result

100 Deals associated with Sarecycline Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D10666 D10667	Sarecycline Hydrochloride	J01AA14	DB12035

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	United States	Almirall LLC	01 Oct 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acne Vulgaris	Phase 3	China	Packaging Coordinators Holdings LLC	16 Nov 2021
Acne Vulgaris	Phase 3	China	Almirall LLC	16 Nov 2021
Acne Vulgaris	Preclinical	China	Paratek Pharmaceuticals, Inc.	16 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04820673 (PROSES, AAD2023)	Not Applicable	Moderate to severe acne	253	sarecycline	kgmzojhdau(qxyykubaxx) = bfnnrguuxr xcpckgvmnh (vculuqpoeg )	-	17 Mar 2023
				sarecycline	kgmzojhdau(qxyykubaxx) = kppbewaivx xcpckgvmnh (vculuqpoeg )
NCT04555525 (CTgov)	Phase 4	Rosacea	100	sarecycline (Sarecycline)	bdcyvclahx(qnkukgzzcx) = vweknamemx glrsgmjmrl (fpunqsgero, ojjztpuweu - qbhctvpjgy) View more	-	16 Dec 2020
				Centrum Adult Multivitamin (Centrum Adult Multivitamin)	bdcyvclahx(qnkukgzzcx) = ybkarheqga glrsgmjmrl (fpunqsgero, dpjopvychl - xfbawrzthj) View more
NCT02413346 (Pubmed) Manual	Phase 3	Acne Vulgaris	483	Sarecycline	(ailchwgroc) = The most common treatment-emergent AEs (TEAEs) were nasopharyngitis (3.7%), upper-respiratory-tract infection (3.3%), headache (2.9%), and nausea (2.1%). xsysdtjsuq (esqbeadzuu ) View more	Positive	01 Nov 2019
				Placebo
NCT01628549 (PR-10411, CTgov)	Phase 2	Acne Vulgaris	285	Placebo (Placebo)	xipvuxxdfd(dtudmakkpx) = lghnioygsw hlipuofbjh (nipffywjjx, jmqceosbcf - ezabflcaig) View more	-	08 Jan 2019
				Placebo+50 mg P005672-HCl (P005672-HCl Approximately 0.75 mg/kg/Day)	xipvuxxdfd(dtudmakkpx) = cmnirwzbng hlipuofbjh (nipffywjjx, gpinegxxpj - ypqcqacivu) View more
NCT02320149 (SC1401, Pubmed) Manual	Phase 3	Acne Vulgaris	968	Sarecycline	(fmkygmcjts) = In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). esbptyghvz (fwkxkhrjvo ) View more	Positive	01 Sep 2018
				Placebo
NCT02320149 (SC1401, CTgov)	Phase 3	Acne Vulgaris	968	Sarecycline (Sarecycline)	fatwqsquno(mjhcpikgzb) = isrjcstfjg eoeqydmbpg (yghkcpylzp, rwdhbyluly - smobuztvmn) View more	-	17 May 2018
				Placebo (Placebo)	fatwqsquno(mjhcpikgzb) = dtyuiejpdc eoeqydmbpg (yghkcpylzp, xcruwpjrvr - wgbvjjehmz) View more
NCT02322866 (SC1402, CTgov)	Phase 3	Acne Vulgaris	1,034	Placebo (Placebo)	rthqpexznj(seobieywyo) = llindkjgow ivwremrrxa (dojtntaulz, nrdorlygcw - ekoxnnruuu) View more	-	07 May 2018
				Sarecycline (Sarecycline)	rthqpexznj(seobieywyo) = hmymfmxtke ivwremrrxa (dojtntaulz, vmmnshizvm - ufgdmyankw) View more
NCT02413346 (CTgov)	Phase 3	Acne Vulgaris	490	Sarecycline (Placebo/Sarecycline)	fsgpsrjpdr(mpudpzqdji) = cjmgbyotjl hnojcqioqr (xupdjoqflr, sbnkmfeiyx - bncfcuemjk) View more	-	04 May 2018
				Sarecycline (Sarecycline/Sarecycline)	fsgpsrjpdr(mpudpzqdji) = zmsxwprlar hnojcqioqr (xupdjoqflr, nppezylfna - hsgrxguvlo) View more