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Details:
A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 (deuterated ruxolitinib) experienced greater scalp regrowth compared to placebo.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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:
CTP-543 (deuterated ruxolitinib) is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. The safety profile seen with CTP-543 in THRIVE-AA1 was consistent with previous studies.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 23, 2022
Details:
Terran plans to quickly accelerate the development of these compounds as important complements to a growing pipeline of both early-stage and late-stage therapeutics and technologies in the CNS space.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Terran Biosciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 11, 2022
Details:
Phase 3 trial for CTP-543 (Deuterated Ruxolitinib) THRIVE-AA clinical program, now fully enrolled and progressing toward completion, our focus will be on efficiently moving to data readout and preparing our New Drug Application.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 January 04, 2022
Details:
CTP-543 is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. CTP 543 is a potential new treatment to address the dysregulated autoimmune function in alopecia areata.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 25, 2021
Details:
CTP-543 has been generally well tolerated in the long-term extension study with only 4 of the 158 subjects entering the study discontinuing due to adverse events to date. Adverse events are consistent with those previously reported in the Phase 2 trials.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 July 01, 2021
Details:
CTP-543, an oral Janus kinase inhibitor, in adult patients with moderate to severe alopecia areata. The Company expects to report topline results from THRIVE-AA2 in the second half of 2022.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 27, 2021
Details:
The company believes that positive results from two Phase 3 trials could serve as the basis for submitting an NDA in early 2023 for CTP-543 for the treatment of moderate to severe alopecia areata in adult patients. CTP-543 is an oral selective inhibitor of JAK1 and JAK2.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 03, 2020
Details:
The data from this long-term extension study show that, relative to previous Phase 2 study results of CTP-543, hair regrowth assessed by the Severity of Alopecia Tool (SALT) was maintained or improved in the vast majority of patients to date.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 29, 2020
Details:
CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2. The FDA has granted CTP-543 Breakthrough Therapy designation for the treatment of adult patients with moderate to severe alopecia areata and Fast Track designation for the treatment of alopecia areata.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 October 13, 2020
Details:
FDA Breakthrough Therapy Designation for CTP-543 is supported by positive data from a Phase 2 clinical trial in patients with moderate-to-severe alopecia areata.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology Product Name: CTP-543
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 July 08, 2020
Details:
The data analyses build on the previously-reported Phase 2 primary efficacy analysis which showed that administration of 8 mg twice-daily and 12 mg twice-daily doses of CTP-543 for 24 weeks produced a statistically significantly number of responders vs placebo.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology 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 June 12, 2020
Details:
Concert discussed key aspects of its planned Phase 3 trials in adult patients with the U.S. Food and Drug Administration (FDA) at a recently conducted End-of-Phase 2 meeting.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology 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 April 01, 2020
Details:
Oral JAK1/JAK2 Inhibitor CTP-543 achieves primary endpoint in patients with Alopecia Areata.
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology 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 February 24, 2020
Details:
The CAFC’s grant of the Company’s motion will take effect on March 16, 2020 unless Incyte Corporation, which filed the petition for the IPR
Lead Product(s): Deuterated Ruxolitinib
Therapeutic Area: Dermatology 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 January 27, 2020
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