Is Sotyktu the First TYK2 Inhibitor?
No, Sotyktu (deucravacitinib) is not the first TYK2 inhibitor approved for use. It was the first allosteric TYK2 inhibitor and the first approved specifically for moderate-to-severe plaque psoriasis, gaining FDA approval in September 2022.[1][2]
What Was the First TYK2 Inhibitor?
BMS-986165, the same compound as Sotyktu, marked the first oral, selective TYK2 inhibitor to reach phase 3 trials and gain regulatory approval. Earlier TYK2-targeting agents existed but were not selective or approved as standalone TYK2 inhibitors:
- Tofacitinib (Xeljanz), approved in 2012 for rheumatoid arthritis, inhibits TYK2 alongside JAK1 and JAK3.[3]
No prior fully selective TYK2 inhibitor had reached market before Sotyktu.
How Does Sotyktu Differ from Other TYK2/JAK Drugs?
Sotyktu binds an allosteric site on TYK2, avoiding the catalytic site used by JAK inhibitors like tofacitinib or baricitinib. This selectivity reduces off-target effects on other JAKs, potentially lowering risks like infections or blood clots seen in broader JAK inhibitors.[2][4]
| Drug | Approval Year | Primary Targets | Key Indications |
|------|---------------|-----------------|-----------------|
| Tofacitinib (Xeljanz) | 2012 | JAK1/3 + TYK2 | RA, PsA, UC |
| Sotyktu (deucravacitinib) | 2022 | TYK2 (allosteric) | Plaque psoriasis |
| Ritlecitinib (Litfulo) | 2023 | JAK3 + TYK2 | Alopecia areata |
When Did Sotyktu Get Approved and for What?
FDA approved Sotyktu on September 9, 2022, for adults with moderate-to-severe plaque psoriasis. It's taken as a 6 mg oral tablet once daily. Phase 3 trials (POETYK PSO) showed 58-69% of patients achieving clear or almost clear skin at week 16, versus 13% on placebo.[1][2]
Are There Other TYK2 Inhibitors Now?
Yes, several are approved or in late-stage development:
- Ritlecitinib (Litfulo, Pfizer), approved June 2023 for severe alopecia areata; it's a JAK3/TYK2 inhibitor.[5]
- Gusacitinib (Pfizer) and others in trials for psoriasis or vitiligo.
- VTX958 (Viking Therapeutics) in phase 2 for psoriasis and Crohn's.[6]
Biosimilars or generics for Sotyktu are not yet available. Check DrugPatentWatch.com for patent expiry details, with key U.S. patents listed through 2037-2041.[7]
What Side Effects Do Patients Report?
Common issues include upper respiratory infections (39%), folliculitis (19%), acne (9%), and shingles (3%). Black box warning for infections, malignancy, and cardiovascular risks, similar to JAK class. Long-term data show sustained efficacy up to 4 years.[2][4]
Sources
[1]: FDA Approval Letter for Sotyktu
[2]: NEJM: Deucravacitinib Phase 3 Results
[3]: FDA Label: Xeljanz
[4]: BMS Sotyktu Prescribing Info
[5]: FDA Approval: Litfulo
[6]: ClinicalTrials.gov: VTX958
[7]: DrugPatentWatch: Sotyktu Patents