Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole

This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.

Start Date01 Jul 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

[+1]

CTRI/2022/01/039430 / RecruitingPhase 3IIT

Triple Arm Randomised Controlled Trial Comparing Metronidazole, Tinidazole And Secnidazole For The Efficacy In The Patients Of Amoebic Liver Abscess (TARMENTS TRIAL) - TARMENTS Trial

Start Date31 Jan 2022

Sponsor / Collaborator-

NCT05033743 / CompletedPhase 2/3IIT

Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study

The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.

Start Date09 Jul 2021

Sponsor / Collaborator

Indiana University

[+1]

100 Clinical Results associated with Secnidazole

100 Translational Medicine associated with Secnidazole

100 Patents (Medical) associated with Secnidazole

224

Literatures (Medical) associated with Secnidazole

01 Nov 2024·Sexually Transmitted Diseases

In Vitro Testing of Trichomonas vaginalis Drug Susceptibility: Evaluation of Minimal Lethal Concentration for Secnidazole That Correlates With Treatment Success

Article

Author: Secor, W. Evan ; Novak, Jan ; Graves, Keonte J. ; Muzny, Christina A. ; Augostini, Peter ; Tiwari, Hemant K.

AbstractWe determined the in vitro minimum lethal concentration of secnidazole and assessed the correlation with clinical susceptibility among Trichomonas vaginalis isolates obtained from 71 women, of whom 66 were successfully treated with this medication. A minimum lethal concentration ≤12.5 μg/mL correlated with clinical susceptibility in this study.

01 Nov 2024·Analytical and Bioanalytical Chemistry

Development of purity certified reference materials to establish metrological traceability for the measurement of nitroimidazoles in agricultural products

Article

Author: Liu, QingYi ; Zhou, Jian ; Jiang, Bin ; Li, FuKai ; Yang, MengRui ; Wang, Min ; Zhang, LiYuan

It is of significant importance to public health that reliable monitoring of nitroimidazoles be conducted, while certified reference materials (CRMs) are essential for accurate and reliable detection. A project has been initiated with the objective of developing nitroimidazole purity CRMs to ensure that results from nationwide monitoring laboratories for nitroimidazoles in antibiotic residues can be compared and traced. The candidates were successively characterized in terms of their structure by means of infrared (IR) spectroscopy and mass spectrometry (MS). The mass balance (MB) method and the quantitative nuclear magnetic resonance (qNMR) method were utilized to determine the purity of nitroimidazoles with remarkable accuracy. Furthermore, a methodical investigation was conducted on homogeneity, stability, and uncertainty. Six nitroimidazole purity CRMs, including tinidazole (GBW09252), secnidazole (GBW09286), ronidazole (GBW09288), metronidazole (GBW(E)090755), dimetridazole (GBW(E)090819), and ornidazole (GBW(E)090820), were finally manufactured following authorization from China's State Administration for Market Regulation (SAMR). By using these CRMs, it is possible to improve the traceability, accuracy, and comparability of nitroimidazole measurements in a range of agricultural products, protecting public health.

01 Oct 2024·The Journal of Antibiotics

Identification of novel antistaphylococcal hit compounds

Article

Author: Tukalo, Michael A ; Volynets, Galyna P ; Yarmoluk, Sergiy M ; Rybak, Mariia Yu ; Moshynets, Olena V ; Vyshniakova, Hanna V ; Gudzera, Olga I ; Borovykov, Oleksiy V ; Prykhod'ko, Andrii O ; Lukashov, Sergiy S ; Iungin, Olga S ; Pletnova, Larysa V ; Balanda, Anatoliy O ; Maiula, Taras H

Staphylococcus aureus is one of the most common nosocomial biofilm-forming pathogens worldwide that has developed resistance mechanisms against majority of the antibiotics. Therefore, the search of novel antistaphylococcal agents with unexploited mechanisms of action, especially with antibiofilm activity, is of great interest. Seryl-tRNA synthetase is recognized as a promising drug target for the development of antibacterials. We have carried out molecular docking of compounds with antistaphycoccal activity, which were earlier found by us using phenotypic screening, into synthetic site of S. aureus SerRS and found seven hit compounds with low inhibitory activity. Further, we have performed search of S. aureus SerRS inhibitors among compounds which were previously tested by us for inhibitory activity toward S. aureus ThrRS, that belong to the same class of aminoacyl-tRNA synthetases. Among them six hits were identified. We have selected four compounds for antibacterial study and found that the most active compound 1-methyl-3-(1H-imidazol-1-methyl-2-yl)-5-nitro-1H-indazole has MIC values toward S. aureus multidrug-resistant clinical isolates ranging from 78.12 to 156.2 µg/ml. However, this compound precipitated during anti-biofilm study. Therefore, we used 3-[N'-(2-hydroxy-3-methoxybenzylidene)hydrazino]-6-methyl-4H-[1,2,4]triazin-5-one with better solubility (ClogS value = 2.9) among investigated compounds toward SerRS for anti-biofilm study. It was found that this compound has a significant inhibitory effect on the growth of planktonic and biofilm culture of S. aureus 25923 with MIC value of 32 µg ml^-1. At the same time, this compound does not reveal antibacterial activity toward Esherichia coli ATCC 47076. Therefore, this compound can be proposed as effective antiseptic toward multidrug-resistant biofilm-forming S. aureus isolates.

News (Medical) associated with Secnidazole

14 Nov 2024

·www.prnewswire.com

Evofem Biosciences Announces Financial Results for the Third Quarter of 2024

— Improved loss from operations by 31% — — Acquired SOLOSEC, a commercially attractive, single-dose oral antibiotic FDA-approved to treat two pervasive sexual health infections — — Forged commercial agreement for Phexxi in Middle East — SAN DIEGO, Nov. 14, 2024 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. ("Evofem" or "the Company") (OTCQB: EVFM) today announced financial results for the third quarter and nine-month period ended September 30, 2024. Highlights include: Acquired global rights to SOLOSEC® (secnidazole) 2g oral granules, a single-dose oral antibiotic FDA approved to treat bacterial vaginosis and trichomoniasis, two common sexual health infections. Licensed Phexxi® (lactic acid, citric acid and potassium bitartrate) commercial rights in the Middle East to Emirati pharmaceutical company Pharma 1 Drug Store. The regulatory submission for the hormone-free contraceptive is on track for submission to the UAE Ministry of Health by year-end 2024. Launched a Market Development Collaboration with Pearsanta focused on its blood-based diagnostic test for endometriosis, a chronic disease associated with severe, life-impacting pain that affects approximately one in ten women of reproductive age. Improved loss from operations to $2.4 million for the third quarter of 2024, versus a loss from operations of $3.6 million in the prior year quarter. Aditxt, Inc. (Nasdaq: ADTX) has invested $5.0 million in Evofem since May 2024, including $1.3 million from the sale of Series F-1 Preferred Stock to Aditxt in the third quarter of 2024 and $2.7 million in October 2024. These investments were stipulated in the Amended and Restated Merger Agreement, as amended (the "A&R Merger Agreement"), between the companies. On November 8, 2024, Evofem remedied its prior bid price deficiency and regained compliance with the OTCQB Standards for Continued Eligibility. "We continue to advance Evofem's strategy to grow revenues organically and through strategic acquisitions and alliances," said Saundra Pelletier, CEO of Evofem Biosciences. "In the third quarter we closed several business development transactions that we expect will diversify and strengthen our revenue streams. We acquired and recently relaunched SOLOSEC as the only single-dose oral treatment FDA-approved for both bacterial vaginosis and trichomoniasis. We also forged an agreement that paves the way for the commercialization of Phexxi in the GCC, starting with the UAE. In addition, we launched a market development collaboration with Pearsanta, a subsidiary of Aditxt, for its endometriosis diagnostic. Further post-merger support from Aditxt and its ecosystem should help catalyze our growth trajectory and our ability to execute our mission to improve women's lives through diversified and differentiated diagnostic, preventive, and therapeutic offerings." Financial Results For the three months ended September 30, 2024, net product sales were $4.5 million compared to $5.1 million in the prior year period. The 12% decrease primarily reflects lower unit sales in the current period due to the impact of the continued absence of marketing, partially offset by the Phexxi WAC increase in January 2024 and a slight decrease in variable consideration. Total operating expenses were $6.9 million, a decrease of 20% compared to the prior year period. Selling and marketing costs were $2.4 million, a decrease of 20% compared to the prior year quarter. General and administrative costs were $3.1 million, a decrease of 4% compared to the prior year quarter. Research and development costs were $0.3 million, a decrease of 46% compared to the prior year quarter. Cost of goods sold (COGS) were $0.9 million, a 54% decrease compared to the prior year period primarily due to the lower product sales and the absence of re-packaging costs in the current year quarter. As a result, operating loss improved to $2.4 million for the third quarter of 2024 as compared to an operating loss of $3.6 million in the third quarter of 2023. Factoring in a $0.1 million gain in other income, net loss attributable to common stockholders was $2.4 million, or a loss of $0.02 per share, for the three months ended September 30, 2024. This compares to net income attributable to common shareholders of $66.0 million, or $15.34 per share, for the prior year quarter, which reflects a $75.3 million gain related to the Baker Fourth Amendment, which was treated as a debt extinguishment, offset in part by a $5.3 million loss on the quarterly valuation of the senior subordinated convertible notes and purchase rights and warrant modifications, and $0.5 million of interest expense related to the Adjuvant Note. Liquidity In the third quarter of 2024, Evofem raised $1.3 million in aggregate net proceeds through the sale and issuance of 1,260 shares of Series F-1 Convertible Preferred Stock to Aditxt pursuant to the A&R Merger Agreement. At September 30, 2024, the Company had $0.7 million of restricted cash, as compared to $0.6 million of restricted cash at December 31, 2023. In October 2024, Evofem raised $2.7 million in aggregate net proceeds through the sale and issuance of 2,740 shares of Series F-1 Convertible Preferred Stock to Aditxt pursuant to the A&R Merger Agreement. Evofem used a portion of this funding to pay in full its obligations to the U.S. Food and Drug Administration. About Evofem Biosciences Evofem Biosciences, Inc., is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt's subsidiary Adifem, Inc. is expected to merge with and into Evofem, with Evofem remaining as the surviving entity and a wholly owned subsidiary of Aditxt. The companies amended and restated the Merger Agreement, as amended (the "A&R Merger Agreement"), in its entirety in July 2024. The A&R Merger Agreement was subsequently amended in August, September, and October 2024, primarily to adjust investment dates. The closing of the transactions is subject to several conditions, including approval of the transactions by a majority of the combined voting power of Evofem's E-1 and Common Stock, voting together as a single class, at a meeting where quorum is present, and Aditxt raising sufficient capital to fund its obligations prior to and at closing. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): Phexxi® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the Company's anticipated financial performance, expected timing of the regulatory submission to the UAE Ministry of Health, and the likelihood of success and anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, Quarterly Report on Form 10-Q for the three and six months ended June 30, 2024 filed with the SEC on August 14, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. Contact Amy Raskopf Evofem Biosciences, Inc. [email protected] (917) 673-5775 [email protected] -- Financial Tables Follow – SOURCE Evofem Biosciences, Inc. 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AcquisitionDrug ApprovalFinancial StatementLicense out/in

17 Jul 2024

·www.businesswire.com

Aditxt and Evofem Amend and Restate Merger Agreement, Targeting September 30 Closing

MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )--Aditxt, Inc. (“Aditxt”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, announces this past Friday, July 12 th , Aditxt, its wholly owned subsidiary Adifem, Inc., and Evofem Biosciences, Inc.’s (“Evofem”) (OTCQB: EVFM) amended and restated their Merger Agreement. This amended and restated Merger Agreement, among others, addresses pre-closing issues critical for Evofem’s future success, including interim financing needs. The other revisions to the Merger Agreement, alongside additional interim financing for Evofem, include substituting cash for Aditxt’s common stock as the consideration for Evofem’s common stock in the merger and additional changes relating to it. Aditxt and Evofem are diligently working to close the contemplated transaction in the second half of 2024. The closing of the transaction between Aditxt and Evofem remains subject to the successful satisfaction of a number of closing conditions, including, but not limited to, Aditxt securing sufficient financing to fund its obligations at closing. No assurance can be given that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close. Evofem recently announced the acquisition of SOLOSEC ® (secnidazole) 2g oral granules from Lupin Limited. Under the transaction terms, Lupin can receive a potential total consideration of up to $84 million based on future contingent milestones. “Aditxt and Evofem share a common vision in recognizing and valuing innovations like SOLOSEC that need additional support to reach their full potential,” said Saundra Pelletier, Chief Executive Officer of Evofem. “The expertise, focus, and tenacity of Evofem's U.S. commercial organization have enabled us to deliver consistent annual net sales growth for Phexxi since its launch. With the addition of Aditxt's platform, we believe can accelerate our growth trajectory and expand into a multi-product women's health franchise. We are excited to harness these strengths and leverage our physician relationships to re-launch and grow SOLOSEC, which offers an attractive ‘one-and-done’ oral dosing regimen for women with bacterial vaginosis and trichomoniasis.” Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented on this announcement, “The acquisition of SOLOSEC marks an important milestone in Evofem’s evolution. We believe that SOLOSEC is a valuable asset that diversifies Evofem’s portfolio and has the potential to accelerate its evolution into a dynamic global women’s health business that addresses significant health challenges. Our commitment to supporting the expansion of Evofem’s portfolio with additional products and broadening its market reach domestically and internationally exemplifies how the Aditxt model operates. Our confidence in Evofem’s potential has only strengthened, and we firmly believe that, if supported by the right resources, they will drive significant advancements in women’s health.” About Aditxt, Inc. Aditxt, Inc.® (“Aditxt”) (NASDAQ: ADTX) is a social innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The social innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model democratizing innovation, ensuring every stakeholder’s voice is heard and valued, empowering collective progress. Aditxt has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing population health, impacting public health globally, and Pearsanta™, Inc. delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, at their CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA. For more information see: www.aditxt.com About SOLOSEC ® SOLOSEC ® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age, and trichomoniasis, a sexually transmitted infection, in people 12 years of age and older. Since trichomoniasis is a sexually transmitted infection, sexual partners of infected patients should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC is designed to be easy to take, and one oral dose contains a complete course of treatment. 1 Additional information about SOLOSEC® can be found at www.SOLOSEC.com . 1 SOLOSEC Package Insert Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute on its strategic M&A initiatives; the Company’s ability obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the Company’s ability to raise additional capital; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

AcquisitionDrug Approval

15 Jul 2024

·www.prnewswire.com

Lupin Divests U.S. Commercial Women's Health Specialty Business to Evofem, including SOLOSEC

MUMBAI, India and NAPLES, Fla. and SAN DIEGO, July 15, 2024 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) announced today that it has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences, Inc. (OTCQB: EVFM) (Evofem), a U.S. biopharmaceutical company focused exclusively on Women's Health. Lupin's U.S. Commercial Women's Health Specialty Business is primarily focused on commercializing SOLOSEC® (secnidazole) 2g oral granules. This FDA-approved single-dose antimicrobial agent provides a complete course of therapy for the treatment of bacterial vaginosis (BV) and trichomoniasis, two common sexual health infections. Continue Reading Lupin Divests U.S. Commercial Women's Health Specialty Business to Evofem, including SOLOSEC Under the terms of the deal, Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones. Dr. Fabrice Egros, President - Global Corporate Development, Lupin, said, "We are very pleased to divest our U.S. Commercial Women's Health Specialty business, including SOLOSEC®, to Evofem. This divestment is another step in aligning our U.S. specialty business with our strategic plan to build our specialty business in therapeutic areas where we have building blocks of synergy. These include respiratory and neurological diseases." "The acquisition of this commercial business aligns with and advances our mission to improve access to innovative and differentiated options that impact women's daily lives. SOLOSEC is a commercially attractive, single-dose oral antibiotic that addresses two pervasive sexual health infections. We can now fully leverage our commercial infrastructure, maximize our strong physician relationships, and re-launch an asset with tremendous growth potential," said Saundra Pelletier, Chief Executive Officer, Evofem. About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector. Please visit for more information. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): About Evofem Biosciences Evofem Biosciences is focused on commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com. In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt intends to acquire Evofem. The parties reinstated and amended the Merger Agreement, as amended, in May 2024 and are working to close the contemplated transaction in the second half of 2024. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): About SOLOSEC® SOLOSEC® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and trichomoniasis, a sexually transmitted infection, in people 12 years of age and older.1-4 Since trichomoniasis is a sexually transmitted infection, sexual partners of infected patients should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take and one oral dose contains a complete course of treatment.[1] Additional information about SOLOSEC® can be found at . References: 1 SOLOSEC Package Insert 2 Workowski KA, Bachmann LH, Chan PA, et al. CDC Sexually Transmitted Diseases Treatment Guidelines, 2001. MMWR Recomm Rep 2021; 70(RR-04):1-192. 3 Onderdonk AB, Delaney ML, Fichorova RN. The Human Microbiome During Bacterial Vaginosis. Clin Microbiol Rev. 2016;29(2):223-238. 4 Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864-869. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in Evofem's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem does not undertake any duty to update any forward-looking statement except as required by law. Photo: Logo: SOURCE Lupin Limited

Drug ApprovalAcquisition

100 Deals associated with Secnidazole

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KEGG	Wiki	ATC	Drug Bank
D07353	Secnidazole	P01AB07	DB12834

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Giardiasis	CN	Ethypharm SAS	16 May 2000
Trichomonas Infections	CN	Ethypharm SAS	16 May 2000
Bacterial Vaginosis	CH	-	01 Jan 1980

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Vaginosis	Phase 3	US	Symbiomix Therapeutics LLC	28 May 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05033743 (CTgov)	Phase 2/3	Bacterial Vaginosis	24	Secnidazole 2 GM Oral Granules	birfjschnz(jlcwdtzkaz) = zocclldzwn zgrmfamjea (idazixutcq, nusorctmvi - zpybnjcleo) View more	-	05 Feb 2024
NCT03935217 (CTgov)	Phase 3	Trichomonas Infections	147	Placebo (Placebo)	vpdrfpytgl(jljbbzbbuy) = msottsouut fmfexyxrpl (nnhgzxgyub, rshugdfloo - ldeajcqhzn) View more	-	04 Oct 2023
				Secnidazole (Solosec (Containing 2 Grams of Secnidazole))	fklmcibdeu(cesblcryyc) = xxscqryqbh gtgohtyhxw (tcdeazrwwp, ichalvhyuv - keykxqluum) View more
NCT03935217 (Pubmed \| Clin Infect Dis) Manual	Phase 3	Trichomonas Infections	147	Secnidazole	(cqyxmhcbqt) = xvolmozsos zgkaavbmau (taowsxzzsa ) View more	Positive	15 Sep 2021
				Placebo	(cqyxmhcbqt) = vxvwtiqwlr zgkaavbmau (taowsxzzsa ) View more
NCT02418845 (CTgov)	Phase 3	Bacterial Vaginosis	189	SYM-1219 (SYM-1219)	pbmsngxfah(revuywasqw) = pqfctbnavd pjylkvtdzd (nbdiwocaiz, eccnxtxoyf - odxvuuxvby) View more	-	13 Apr 2021
				Placebo (Placebo)	pbmsngxfah(revuywasqw) = qzngirogly pjylkvtdzd (nbdiwocaiz, ufacvnlkxh - rgvtoqmfsc) View more
NCT02452866 (CTgov)	Phase 3	Bacterial Vaginosis	325	SYM-1219	ejyzqzwmhm(rlclkkmmxc) = thrnnuenbo pbdzpppuws (dmpsrkobpi, ejifkjxjxb - malydhsrbn) View more	-	13 Apr 2021
NCT02452866 (Pubmed \| J Womens Health (Larchmt)) Manual	Phase 3	Bacterial Vaginosis	283	secnidazole	(rgyjpydwot) = vulvovaginal mycotic infection 5.3%, nausea 4.4%, and dysgeusia 3.1% ewtksfvbiu (issalejvwn )	Positive	01 Apr 2018
NCT02147899 (CTgov)	Phase 2	Bacterial Vaginosis	215	SYM-1219 (SYM-1219 Low Dose)	xaqedhjstx(vywguhpkni) = wddyhinrsa yukzbvxojf (pukbxlptpn, hquilcupzi - yvfqvtitzo) View more	-	14 Dec 2017
				SYM-1219 (SYM-1219 High Dose)	xaqedhjstx(vywguhpkni) = gfiueigquj yukzbvxojf (pukbxlptpn, iserfxawyz - oqfgfaxxnx) View more
NCT02418845 (Pubmed \| Am J Obstet Gynecol) Manual	Phase 3	Bacterial Vaginosis	189	secnidazole	(cjqzmvsupi) = uhijytetct wrewnywgmd (sydujpoyfr ) View more	Positive	01 Dec 2017
				Placebo	(cjqzmvsupi) = ylkrlyvqax wrewnywgmd (sydujpoyfr ) View more
NCT02147899 (Pubmed \| Obstet Gynecol)	Phase 2	Bacterial Vaginosis	215	Secnidazole 1g	(mjvzctbrtf) = qxoswlhsxy ywxppqtzdh (jmtycnlnmb ) View more	Positive	01 Aug 2017
				Secnidazole 2g	(mjvzctbrtf) = fjwvglzshm ywxppqtzdh (jmtycnlnmb ) View more

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