this new drug was mentioned in the Xeljanz thread but I thought that since it's so difficult to keep track of information on the format of this forum it should have it's own thread

Can we try to keep this thread on topic with any information about CTP-543 that anyone happens to come across?

LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced its next product candidate, CTP-543, for the treatment of alopecia areata. Alopecia areata is an autoimmune disease characterized by patchy or widespread hair loss, for which there is significant unmet medical need and currently no FDA-approved treatment. CTP-543 is a deuterium-modified analog of ruxolitinib, which selectively inhibits Janus kinases 1 and 2, known as JAK1 and JAK2. Ruxolitinib is commercially available under the name Jakafi® in the United States for the treatment of myelofibrosis and polycythemia vera. Concert expects to initiate Phase 1 clinical evaluation of CTP-543 in the second quarter of 2016 with efficacy studies commencing in 2017.

Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been shown to promote hair growth in individuals with moderate to severe disease. Preclinical studies conducted by the Company demonstrated that CTP-543 retains ruxolitinib’s selective JAK 1/2 inhibition profile and shows improved metabolic stability.

“We are very excited about the potential of CTP-543 to greatly enhance patient care for individuals with alopecia areata. CTP-543 represents an opportunity to address an important disease where new and effective treatment options are needed,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “Based on demonstrated clinical activity of ruxolitinib in alopecia areata, CTP-543 has the potential to become an important first-in-class oral medicine to treat a devastating condition affecting millions of people in the U.S.”

Recently, the U.S. Patent and Trademark Office issued U.S. Patent No. 9,249,149 that claims CTP-543 as a novel composition of matter.

“CTP-543 is a prime example of the application of our deuterium platform to create proprietary new medicines which enhance and extend the utility of known molecules into new therapeutic areas. We believe we have developed a valuable, potentially first-in-class new drug candidate for an important unmet medical need and look forward to advancing CTP-543 into clinical evaluation shortly,” said Dr. Tung.

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this is great news! first fast tracked now breakthrough designation! 

I just noticed that Baricitinib was also recently granted break through status. 

it's nice to see the FDA is paying attention to our needs

What does this mean? Does this mean it's available for us now? If not, when do you think it'll be available to us?


Sound promising but what does this mean for us? With these fast track and breakthrough status is it possible to get it approved whilst being in phase 3?

Does anyone know what is the quickest drug to come up market with these statuses?

Thank you 

kind regards 

hello actually the marketing can gain 8 to 12 months.
but hey I think in 2023 see 2024 the best informed are those who are in clinical trials

My knowledge is very limited on timing. 

I did talk to one of the clinical trial coordinators for the phase 3 Phizer trial and she advised often drug companies file with the FDA to goto market prior to completion of the Phase 3 trial and based on the results of Phase 2.  With Phase 3 to be used to continue to monitor results and safety. 

I’ve also talked to one of the clinical trial coordinators that works with Concert and they just said it would depend on the results on ongoing trials.  

My hope would be sometime next year seeing the designations the CTP drug has gotten from the FDA and also the fact the phase 3 trial is at a shorter duration of 24 weeks. 

But who knows. It could be much longer. 

Thanks guys for clearing that up ! Yeh they do look promising as my doctor said they are more selective kala which could mean hopefully more safer to have long term. 

I believe it’s possible with the FDA monitoring closely that a we could get a treatment for alopecia within the next 12-24 months.

However am from UK and where behind so won’t be in the uk for Atleast 3 years 

any updates on this? when will it be approved and how is everyone doing on it?



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