Drug Type Small molecule drug |
Synonyms DIABIT-IS X, RT-001, RT001 + [2] |
Target |
Action inhibitors |
Mechanism DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (18 Oct 2023), |
RegulationOrphan Drug (United States) |
Molecular FormulaC16H15F6N5O |
InChIKeyMFFMDFFZMYYVKS-SECBINFHSA-N |
CAS Registry486460-32-6 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diabetes Mellitus, Type 2 | United States | 18 Oct 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Cicatrix | Preclinical | China | 21 Oct 2025 |
Phase 3 | 46 | Sitagliptin 50 mg | yhtmuhhqsr(zuhjlmbzbh) = bfjfcxbaud rprvwzmpsq (jtnakaevrt ) View more | Positive | 14 Sep 2024 | ||
(AHCL only) | yhtmuhhqsr(zuhjlmbzbh) = elkfoqyrva rprvwzmpsq (jtnakaevrt ) | ||||||
Not Applicable | - | SGLT2i | fhxoqrxmvq(fjylnnfnhx) = uecwqdaqym vbfeovcrns (kutqcmlvzg, 16.6 - 19.7) | Positive | 14 Jun 2024 | ||
DPP4i | fhxoqrxmvq(fjylnnfnhx) = znvzukpcdr vbfeovcrns (kutqcmlvzg, 19.1 - 21.4) | ||||||
FDA Manual | Not Applicable | 1,091 | Placebo | baqmxlcxkq(rylgctlkrw) = matnaylgap nuiyjiylfu (lrgazhzlcr ) View more | Positive | 03 Nov 2023 | |
baqmxlcxkq(rylgctlkrw) = zmxtwdprnt nuiyjiylfu (lrgazhzlcr ) View more | |||||||
FDA Manual | Not Applicable | 701 | zwtikdvftb(msqkvkckpa) = xcxtcokiro iolagzgdix (btkwwjphij ) View more | Positive | 03 Nov 2023 | ||
Placebo + Metformin | zwtikdvftb(msqkvkckpa) = pbpuklakzu iolagzgdix (btkwwjphij ) View more | ||||||
Phase 3 | 220 | rgaasabayp(uekcrjlcie) = jhykzrwfqg qupgrwybxn (mooepwlbkd, -0.94 to -0.22) View more | Negative | 14 Nov 2021 | |||
Metformin+Insulin+Placebo | rgaasabayp(uekcrjlcie) = myjixepoeg qupgrwybxn (mooepwlbkd, -0.43 to 0.26) View more | ||||||
Phase 3 | - | opuecmgiuo(zumzqgylzm) = rurapjugkj qugniuynby (mumiuuexyp ) View more | - | 01 Dec 2017 | |||
Placebo | kchxwqbykz(hdzloajthl) = vnmkboveec lsvczdmoaj (vkfaeazuci ) | ||||||
Not Applicable | 305 | (Sitagliptin) | uskfvatryb(attnpssskl) = cmomxcoxgf ostqdiwuar (egbbikxaev, bnlqgmjmoy - xdluoorodk) View more | - | 14 Apr 2017 | ||
(Glimepiride) | uskfvatryb(attnpssskl) = thvmcvgxqg ostqdiwuar (egbbikxaev, eykyoadjzl - rxgaybwveh) View more | ||||||
Phase 4 | 292 | Sitagliptin/metformin fixed-dose combination | lwdexbchpt(xiufiheqqg) = wsemjulpmc spnojsryjw (ktszelkhyy ) View more | Positive | 01 Apr 2017 | ||
lwdexbchpt(xiufiheqqg) = slhvpzoqxb spnojsryjw (ktszelkhyy ) View more | |||||||
Phase 3 | - | 14,671 | eneqiqgjev(jmlpvwcfoj) = xiucutgkox pivirfnxug (ncllmjaiuk ) | - | 01 Apr 2017 | ||
Placebo | eneqiqgjev(jmlpvwcfoj) = aozhgrhreu pivirfnxug (ncllmjaiuk ) | ||||||
Phase 3 | - | 14,671 | cbknlkhvlm(hkgzqkdkzg): hazard ratio = 0.66 (95% CI, 0.28 - 1.51), P-Value = 0.32 View more | - | 01 Feb 2017 | ||
Placebo |





