X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
Through the acquisition of Evofem, Aditxt gains access to its first and only FDA-approved hormone-free contraceptive gel, Phexxi (lactic acid, citric acid, and potassium bitartrate).
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aditxt
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 12, 2023
Details:
revyve™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations.
Lead Product(s): Edetate Calcium Disodium,Citric Acid
Therapeutic Area: Podiatry Product Name: Revye
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
coactiv+ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations.
Lead Product(s): EDTA acid,Citric Acid
Therapeutic Area: Podiatry Product Name: coactiv+
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
Under the cooperation agreement, DKSH HK will provide full-agency services including key account management, marketing promotion, supply chain, and distribution for Bentrio (bentonite) Nasal Spray sales operation in Hong Kong and Macau.
Lead Product(s): Bentonite,Mono Propylene Glycol,Citric Acid
Therapeutic Area: Immunology Product Name: Bentrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DKSH
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 28, 2022
Details:
Phexxi® (lactic acid, citric acid and potassium bitartrate) vaginal gel provides women an in-the-moment contraceptive that can be easily applied 0-60 minutes before each act of intercourse and works by maintaining the baseline vaginal pH environment.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2022
Details:
Phexxi (L-lactic Acid) is a hormone-free, woman-controlled contraceptive gel. It works by maintaining vaginal pH in the optimal range of 3.5 to 4.5, which is inhospitable to sperm, as well as certain bacterial and viral pathogens including chlamydia and gonorrhea.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2022
Details:
Phexxi (L-lactic Acid) is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
Defencath is available in Europe and other territories under the brand name Neutrolin. It is used for catheter-related bloodstream infections in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
Lead Product(s): Taurolidine,Citric Acid,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Defencath
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
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.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Phexxi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel, an on-demand method of birth control used to prevent pregnancy.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
Phexxi's (L-lactic Acid) mechanism of action through vaginal pH modulation results in the immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2022
Details:
Evofem intends to use the proceeds from the offering for the continuation of commercialization activities related to its commercial product, Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel, the continuation of its registrational Phase 3 clinical trial.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler & Co.
Deal Size: $26.6 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 20, 2022
Details:
Evofem intends to use the net proceeds from the offering for the continuation of commercialization activities related to its commercial product, Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering May 19, 2022
Details:
Initially, Bora will manufacture Phexxi for nations currently considering formal regulatory approval of Phexxi (L-lactic Acid), for the prevention of pregnancy, including Mexico and Nigeria.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bora Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 10, 2022
Details:
New data from the Phase 3 AMPOWER clinical trial of Phexxi® (lactic acid, citric acid, and potassium bitartrate) showed that women enrolled in the AMPOWER trial had fewer urinary tract infections (UTIs) compared to the general population.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2022
Details:
88.7% of women using Phexxi® (lactic acid, citric acid, and potassium bitartrate vaginal gel) improved or maintained their sex life according to exploratory data collected during the phase 3 ampower clinical trial.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
DefenCath is being developed as a catheter lock solution with an initial indication of use for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with renal failure who are receiving chronic hemodialysis via a central venous catheter.
Lead Product(s): Taurolidine,Citric Acid,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Defencath
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2022
Details:
Phexxi® (lactic acid, citric acid and potassium bitartrate) vaginal gel provides women an in-the-moment contraceptive that can be easily applied 0-60 minutes before each act of intercourse and works by maintaining the baseline vaginal pH environment.
Lead Product(s): Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2021
Details:
Evofem will use the proceeds for the commercialization activities related to Phexxi® (lactic acid, citric acid and potassium bitartrate), the continuation of its Phase 3 clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea in women.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Keystone Capital Partners
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing October 12, 2021
Details:
Evofem intends to use the net proceeds from this offering for the continuation of full commercialization activities related to Phexxi® (lactic acid, citric acid and potassium bitartrate) including other R&D and corporate purposes.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 21, 2021
Details:
Participants reported that adherence with use of EVO100 was related to product satisfaction and the impact on global sexual satisfaction as well as efficacy.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Infections and Infectious Diseases Product Name: EVO100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2021
Details:
This double-blinded, placebo-controlled study of EVO100 met its primary and secondary efficacy endpoints, with statistically significant reductions in the risk of chlamydia and gonorrhea infections.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Infections and Infectious Diseases Product Name: EVO100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
Two posters on data sets from Evofem's Phase 3 AMPOWER trial evaluating Phexxi will be presented at the conference: Sexual Satisfaction with Phexxi: Results from the AMPOWER Clinical Trial Perfect–Use Pregnancy Rates with Phexxi.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2021
Details:
Evofem intends to use the net proceeds from the offering for the continuation of full commercialization activities related to Phexxi® (lactic acid, citric acid and potassium bitartrate) contraceptive vaginal gel in the United States.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Morgan Stanley
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 24, 2021
Details:
EVOGUARD of EVO100 was initiated and the first patient was enrolled in October 2020, and study enrollment targets were met in both October and November 2020 despite the ongoing COVID-19 pandemic.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Infections and Infectious Diseases Product Name: EVO100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
Details:
EVOGUARD is a double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of EVO100 for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhea infection in women.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: EVO100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
Proceeds from the sale of the notes will be used to support EVOGUARD, Evofem's planned Phase 3 clinical trial of EVO100 for the prevention of urogenital chlamydia and gonorrhea in women, and to expand global market access for Phexxi™ vaginal contraceptive gel.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: EVO100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adjuvant Capital
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 15, 2020
Details:
AMPOWER was a single-arm, open-label Phase 3 study designed to evaluate the efficacy and safety of Phexxi™ (lactic acid, citric acid and potassium bitartrate) in preventing pregnancy.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: EVO100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
Approved by the U.S. Food and Drug Administration (FDA) on May 22, 2020, Phexxi is a vaginal pH modulator designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
U.S. FDA has accepted for filing the Company’s submitted New Drug Application (NDA) for Defencath™, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI).
Lead Product(s): Taurolidine,Citric Acid,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Defencath
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
The Company plans to use the net proceeds for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath™ in the U.S., research and development, and working capital and capital expenditures.
Lead Product(s): Taurolidine,Citric Acid,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Defencath
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SunTrust Robinson Humphrey
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering July 27, 2020
Details:
The final data analysis demonstrated a cumulative pregnancy rate of 13.7% over seven cycles of use in Phexxi group.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
Defencath is being developed as a catheter lock solution with an initial indication for use of preventing catheter-related bloodstream infections (CRBSIs) in patients with end-stage renal disease who are receiving hemodialysis via a central venous catheter.
Lead Product(s): Taurolidine,Citric Acid,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Defencath
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2020
Details:
Data demonstrate high efficacy rates of more than 93% when Phexxi is used as directed, also underscore the sexual satisfaction and lubricating factors experienced by women in the AMPOWER trial.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
Details:
Funding to support the company's launch and commercialization plans for PHEXXI™.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 27, 2020
Details:
Data demonstrate high efficacy rates of more than 93% when Phexxi is used as directed, also underscore the sexual satisfaction and lubricating factors experienced by women in the AMPOWER trial.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2020
Details:
Phase 2b AMPREVENCE trial met its primary and secondary endpoints of reducing the risk of chlamydia and gonorrhea infection, respectively, and demonstrated that EVO100 was generally safe and well tolerated.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
