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Details:
BT-600 is a drug device combination containing liquid formulation of tofacitinib (JAK inhibitor). It is being evaluated for the treatment of ulcerative colitis
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2024
Details:
Biora intends to use the net proceeds from this offering to support its operations, complete its ongoing BT-600 (tofacitinib) clinical trial for the treatment of moderate to severe ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 03, 2024
Details:
Biora intends to use the proceeds to complete its ongoing clinical trial of BT-600, a drug-device combination consisting of the orally administered NaviCap device which delivers a unique, liquid formulation of tofacitinib to the colon for moderate to severe ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 01, 2024
Details:
BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2024
Details:
BT-600 (tofacitinib) is a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib. It is being evaluated for the treatment of Ulcerative Colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Details:
BT-600 program consists of a unique, liquid formulation of tofacitinib delivered to the colon via the NaviCap device, for the treatment of ulcerative colitis. Company has submitted an updated Investigational New Drug (IND) application for the same.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2023
Details:
BT-600, a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the treatment of moderate to severe ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2023
Details:
BT-600 (tofacitinib) is a drug/device combination delivering a liquid formulation of tofacitinib via the NaviCap™ platform for the treatment of ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Details:
The net proceeds will be used to invest in research and development of Biora's oral biotherapeutics platform, NaviCap™, a drug delivery system designed for delivery of BT-600, an orally delivered liquid formulation of tofacitinib for the treatment of ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $8.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 14, 2023
Details:
The net proceeds will be used to invest in research and development of Biora's oral biotherapeutics platform, NaviCap™, a drug delivery system designed for delivery of BT-600, an orally delivered liquid formulation of tofacitinib for the treatment of ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: BT-600
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $8.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 13, 2023
Details:
AC-1101 (tofacitinib) topical gel phase I study patients with granuloma annulare. The oral formulation of tofacitinib has already been FDA approved to treat such ailments as rheumatoid arthritis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Rare Diseases and Disorders Product Name: AC-1101
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2023
Details:
Tofacitinib is a janus kinase (JAK) inhibitor which causes gut inflammation in ulcerative colitis. Thus, by blocking JAK tofacitinib reduces inflammation in UC patients.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: Xeljanz-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2023
Details:
The funding will be used in the randomized controlled trial which will investigate the safety and effectiveness of three different treatments for Down syndrome regression disorder. Lorazepam is an anti-anxiety medication that treats catatonia and other symptoms.
Lead Product(s): Lorazepam,Tofacitinib Citrate
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: $5.3 million Upfront Cash: Undisclosed
Deal Type: Funding January 25, 2023
Details:
PGN-600 is an orally delivered liquid formulation of tofacitinib for the treatment of ulcerative colitis. Tofacitinib is a Janus Kinase (JAK) inhibitor which causes gut inflammation in ulcerative colitis. Thus, by blocking JAK tofacitinib reduces inflammation.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: PGN-600
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
Mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 (tofacitinib) treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle treated lesions at week 4 (p=0.228, OC, ITT).
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2022
Details:
FMX114 (tofacitinib), is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation in AD.
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
Reducing systemic uptake with PGN-600 could enable combination therapy to target multiple inflammatory pathways. The study supports the hypothesis that a tissue concentration of tofacitinib at or exceeding IC90 is directly correlated to improvement in patient outcomes.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: PGN-600
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
FMX114, an investigational combination gel formulation of tofacitinib and fingolimod, demonstrated a statistically significant reduction in both absolute and percent change in ADSI score compared to vehicle at week 2.
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
Patient data for PGN-600 (tofacitinib) establishes key correlations for therapeutic exposure in tissue and alternative inflammatory pathways, supporting the hypotheses of targeted therapeutic delivery and potential combination therapy for ulcerative colitis.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: PGN-600
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
USFDA has approved the supplemental NDA (sNDA) for XELJANZ (tofacitinib citrate) for the treatment of adults with active ankylosing spondylitis and the approval is based on data from a Phase 3.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Immunology Product Name: Xeljanz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2021
Details:
FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod for the treatment of mild-to-moderate atopic dermatitis (AD).
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Immunology Product Name: Xeljanz
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 20, 2021
Details:
Pfizer has reported that its rheumatoid arthritis drug, tofacitinib, lowered the cumulative occurrence of death or respiratory failure in Covid-19 pneumonia patients, meeting the primary goal of the STOP-COVID study in Brazil.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xeljanz
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 June 16, 2021
Details:
Initial analysis of the study results suggests PGN-600 was well tolerated, the DDS functioned as intended in the majority of doses, and resulted in significantly higher tofacitinib concentrations in colon tissue.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology Product Name: PGN-600
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
Health Canada is informing Canadians and health care professionals that it is conducting a safety review of Xeljanz and Xeljanz XR (tofacitinib) after a clinical trial identified an increased risk of serious heart-related issues and cancer in trial participants.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Immunology Product Name: Xeljanz
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2021
Details:
The co-primary endpoints of this study were non-inferiority of tofacitinib compared to TNFi in regard to major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer (NMSC)).
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Immunology Product Name: Xeljanz
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2021
Details:
The study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 response, respectively, compared to placebo at week 16.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Immunology Product Name: Xeljanz
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 November 06, 2020
Details:
Zydus Cadila has received tentative approval from US Food and Drug Administration (FDA) to market tofacitinib extended-release tablets, 11 mg.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Gastroenterology 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 October 19, 2020
Details:
With this approval XELJANZ becomes the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Immunology Product Name: Xeljanz
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 28, 2020
Details:
Health Canada has approved Ancheng Biotech's open-label, fixed-sequence, two-period, comparative bioavailability study of AC-1101 (Tofacitinib Citrate). Tofacitinib Citrate is a topical JAK inhibitor for the treatment of vitiligo.
Lead Product(s): Tofacitinib Citrate
Therapeutic Area: Dermatology Product Name: AC-1101
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020
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