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Realgar-indigo naturalis is an arsenic medicine taken by mouth, developed in China, for acute promyelocytic leukaemia. It does the same job as arsenic trioxide, which is given by drip, and the WHO lists it as an essential medicine.
The realgar-indigo naturalis formulation is on the WHO Model List of Essential Medicines among the cytotoxic medicines, as a 270 mg oral tablet containing 30 mg of tetra-arsenic tetra-sulfide, for acute myeloid leukaemia with recurrent genetic abnormalities; it was added in 2019 (TRS 1021). It is an oral form of arsenic used against acute promyelocytic leukaemia. In a multicentre randomised trial of 108 people with non-high-risk acute promyelocytic leukaemia (Haematologica 2025, NCT02899169), consolidation with tretinoin plus the oral formula was non-inferior to tretinoin plus intravenous arsenic trioxide: disease-free survival at two years was 97 per cent and 98 per cent, no deaths were observed after a median follow-up of 29 months, and most side effects were moderate. A mechanism study (PNAS 2008) found tetra-arsenic tetra-sulfide to be the principal component, with indirubin and tanshinone IIA as helpers. The sources read here do not give its national approval history. No regulator's marketing authorisation was read for this page, so its approval status is left open here.
Its main active ingredient is tetra-arsenic tetra-sulfide, from the mineral realgar; with indirubin (from Indigo naturalis) and tanshinone IIA (from Salvia miltiorrhiza) it increased the breakdown of the PML-RARα fusion protein (PML joined to the retinoic acid receptor alpha, RARA) that drives acute promyelocytic leukaemia, and pushed the leukaemia cells to mature, in mouse and cell studies (PNAS 2008). Connects to Retinoic acid receptor alpha (RARA).
1.Realgar-indigo naturalis formulation slips into a pocket on Retinoic acid receptor alpha (RARA).
| Region | Year | Indication |
|---|---|---|
| WHO | 2019 | Essential Medicines List, cytotoxic medicines: acute myeloid leukaemia with recurrent genetic abnormalities (acute promyelocytic leukaemia) · WHO EML listing (TRS 1021), not a marketing authorisation |
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Query for this drug: (TITLE:"Realgar-indigo naturalis formulation" OR ABSTRACT:"Realgar-indigo naturalis formulation" OR TITLE:"realgar-indigo naturalis formula" OR ABSTRACT:"realgar-indigo naturalis formula" OR TITLE:"realgar-indigo naturalis" OR ABSTRACT:"realgar-indigo naturalis" OR TITLE:"RIF" OR ABSTRACT:"RIF" OR TITLE:"tetra-arsenic tetra-sulfide" OR ABSTRACT:"tetra-arsenic tetra-sulfide") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Realgar-indigo naturalis formulation, not a curated reading list.
Shares the tags universe-gap, who-eml.
Shares the tags universe-gap, who-eml.
Shares the tags universe-gap, who-eml.
Shares Tretinoin (all-trans retinoic acid, ATRA), Arsenic trioxide, Acute promyelocytic leukaemia, Acute myeloid leukaemia.
Shares Tretinoin (all-trans retinoic acid, ATRA), Arsenic trioxide, Acute myeloid leukaemia.
Shares Tretinoin (all-trans retinoic acid, ATRA), Arsenic trioxide, Acute promyelocytic leukaemia.
Shares Tretinoin (all-trans retinoic acid, ATRA), Arsenic trioxide, Acute myeloid leukaemia.
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