Drugs / Rovadicitinib
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06388759 | Aug 2022 → Aug 2025 | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04944043 | Jun 2021 → Jun 2023 overdue | chronic graft versus host disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06300320 | May 2024 → Oct 2025 overdue | chronic graft versus host disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06682169 | Nov 2024 → Oct 2029 expected | chronic graft versus host disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-02-28 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory FIC新药获批！正大天晴JAK/ROCK抑制剂罗伐昔替尼开启骨髓纤维化一线治疗新范式 cttq.com ↗
2月28日，正大天晴1类创新药罗伐昔替尼片（安煦®，TQ05105）在国内获批上市，用于中危-2或高危的原发性骨髓纤维化（PMF）、真性红细胞增多症后骨髓纤维化（PPV-MF）或原发性血小板增多症后骨髓纤维化（PET-MF）成年患者的一线治疗。 |
| 2025-08-07 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴罗伐昔替尼片（JAK/ROCK抑制剂）纳入突破性治疗药物程序 cttq.com ↗
近日，正大天晴1类新药罗伐昔替尼片（Rovadicitinib，TQ05105）纳入突破性疗法，用于慢性移植物抗宿主病（cGVHD）的治疗。 |
| 2025-06-18 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 激素耐药aGVHD患者福音！罗伐昔替尼亮相EHA 2025，口头报告Ib期临床结果 cttq.com ↗
对于激素耐药的aGVHD患者，28天总体缓解率达84%，肠道缓解率高达80%，呈现出反应率高、起效迅速、持久缓解的特点。 |
| 2025-01-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴罗伐昔替尼在美获批临床 国内治疗骨纤维化适应症上市申请已获受理 cttq.com ↗
1月14日，正大天晴自主研发的一款具有全新化学结构的JAK/ROCK抑制剂罗伐昔替尼片（TQ05105）II期临床试验申请（IND）获得美国食品药品监督管理局（FDA）批准，拟用于治疗慢性移植物抗宿主病（cGVHD）。 |
| 2024-07-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴1类创新药罗伐昔替尼片（Rovadicitinib）上市申请获受理 cttq.com ↗
7月13日，国家药监局药品审评中心（CDE）官网公示，正大天晴1类新药罗伐昔替尼片（Rovadicitinib，TQ05105）上市申请已获得受理，用于治疗中高危骨髓纤维化（MF）。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-28 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | FIC新药获批！正大天晴JAK/ROCK抑制剂罗伐昔替尼开启骨髓纤维化一线治疗新范式 cttq.com ↗ |
| 2025-08-07 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴罗伐昔替尼片（JAK/ROCK抑制剂）纳入突破性治疗药物程序 cttq.com ↗ |
| 2025-06-18 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 激素耐药aGVHD患者福音！罗伐昔替尼亮相EHA 2025，口头报告Ib期临床结果 cttq.com ↗ |
| 2025-01-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴罗伐昔替尼在美获批临床 国内治疗骨纤维化适应症上市申请已获受理 cttq.com ↗ |
| 2024-07-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴1类创新药罗伐昔替尼片（Rovadicitinib）上市申请获受理 cttq.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rovadicitinib | “Rovadicitinib (TQ05105) is a novel, oral dual Janus kinase 1/2 and rho-associated coiled-coil-containing protein kinase-1/2 inhibitor targeting inflammatory and fibrotic...” PMID 40009501 ↗ Jun 20253“Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.” NCT06300320 ↗ “Rovadicitinib (TQ05105) is a first-in-class, oral, small-molecule Janus kinase (JAK)/Rho-associated kinase (ROCK) inhibitor.” PMID 40752760 ↗ Aug 2025 |
| Known as | TQ05105 | “Rovadicitinib (TQ05105) is a novel, oral dual Janus kinase 1/2 and rho-associated coiled-coil-containing protein kinase-1/2 inhibitor targeting inflammatory and fibrotic...” PMID 40009501 ↗ Jun 20252“Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.” NCT06300320 ↗ “Rovadicitinib (TQ05105) is a first-in-class, oral, small-molecule Janus kinase (JAK)/Rho-associated kinase (ROCK) inhibitor.” PMID 40752760 ↗ Aug 2025 |
| Action | Inhibit | “TQ05105 tablet is a Janus Kinase (JAK) inhibitor, which can inhibit the abnormal activation of JAK 2-V617F mutation, thereby inhibiting the sustained abnormal activation of JAK...” NCT04944043 ↗ |
| Modality | Small molecule | “Rovadicitinib (TQ05105) is a first-in-class, oral, small-molecule Janus kinase (JAK)/Rho-associated kinase (ROCK) inhibitor.” PMID 40752760 ↗ Aug 2025 |
| Route | Oral | “TQ05105 tablet 10mg given orally” NCT04944043 ↗ |
| Target | ROCK2 | “It can inhibit the sustained abnormal activation of the Janus kinase (JAK) signal transducer and activator of transcription (JAK-STAT) pathway and also inhibit Rho associated...” NCT06682169 ↗ |