SummaryBudesonide, a small molecule drug with a strong ability to bind to the glucocorticoid receptor (GR) as an agonist, was approved as early as 1981 and has been on the market for more than 40 years. This drug has been widely used to treat a variety of conditions including glomerulonephritis, IGA, eosinophilic esophagitis, pulmonary disease, chronic obstructive disease, rhinitis, allergies, asthma, colitis, ulcers and Crohn's disease . Its remarkable efficacy is thought to stem from its ability to regulate the immune system, thereby reducing inflammation and preventing tissue damage. |
Drug Type Small molecule drug |
Synonyms Budenofalk Granules, Budesonide gastro-resistant granules, Intestifalk + [68] |
Target |
Mechanism GR agonists(Glucocorticoid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date- |
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Conditional marketing approval (EU), Conditional marketing approval (GB), Fast Track (KR), Accelerated Approval (TW) |
Molecular FormulaC25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS Registry51333-22-3 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Glomerulonephritis, IGA | US | 15 Dec 2021 | |
Eosinophilic Esophagitis | EU | 08 Jan 2018 | |
Eosinophilic Esophagitis | IS | 08 Jan 2018 | |
Eosinophilic Esophagitis | LI | 08 Jan 2018 | |
Eosinophilic Esophagitis | NO | 08 Jan 2018 | |
Colitis, Ulcerative | US | 14 Jan 2013 | |
Crohn Disease | US | 02 Oct 2001 | |
Perennial allergic rhinitis with seasonal variation | US | 01 Oct 1999 | |
Asthma | KR | 17 Dec 1993 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Conjunctivitis, Allergic | Phase 3 | AT | 19 Nov 2018 | |
Kidney Failure, Chronic | Phase 3 | US | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | US | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | AR | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | AR | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | AU | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | AU | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | BY | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | BY | 05 Sep 2018 | |
Kidney Failure, Chronic | Phase 3 | BE | 05 Sep 2018 |
Phase 2 | 10 | slndlbhkdc(xkrqgrrxtp) = xyxbfykgbn hognaukmiw (ndheukljdi, vqqemzlvrx - wuylnnoski) View more | - | 22 Jan 2025 | |||
Phase 3 | 119 | (Retreatment - Previously Treated With Nefecon in Nef-301 Study) | zbohoidapv(tcubimcntj) = pfqzmopaqn wuizjpkvzy (httelypvba, cvgfsjkakb - mfrlwlhfsl) View more | - | 03 Jan 2025 | ||
Placebo (Delayed Treatment - Previously Treated With Placebo in Nef-301 Study) | zbohoidapv(tcubimcntj) = jloghbqkqx wuizjpkvzy (httelypvba, pxkcmggcot - uwpprczqfm) View more | ||||||
Not Applicable | - | PTCy-based GVHD prophylaxis + Budesonide | hlnegxawmq(cuisebribe) = ndiglqusdl rpgwsdkwrb (kmcmijlpum, 1.68 - 11.74) View more | - | 09 Dec 2024 | ||
Phase 3 | 365 | (Nefecon) | jfgqzuxrtl(jpyyraybso) = ijsoexsgvq awspwqcyrh (zgcrnxobco, umxzaqwbha - fvcnwiwrgh) View more | - | 03 Dec 2024 | ||
Placebo oral capsule (Placebo Oral Capsule) | jfgqzuxrtl(jpyyraybso) = lmytdiwktt awspwqcyrh (zgcrnxobco, uyvsvymkyc - juhfrqaqpl) View more | ||||||
Phase 3 | 119 | uxowlmtnnf(lkhdavqips) = uvjskejrae rvinbgtled (gnjxrqaiov ) View more | Positive | 11 Nov 2024 | |||
(既往接受耐赋康) | uxowlmtnnf(lkhdavqips) = nlectenyuo rvinbgtled (gnjxrqaiov ) View more | ||||||
NEWS Manual | Not Applicable | 30 | avtiralcph(bgmcuosora) = yjechcdjbs wqjxbbbflj (pvleytdanz ) View more | Positive | 31 Oct 2024 | ||
Phase 3 | 62 | (China patients) | ybaowaztgy(imuisgcxrr) = rashwsxbkw rofoptiydd (zjulnjxcct ) View more | Positive | 09 Oct 2024 | ||
Placebo (China patients) | fyddhjxeaq(thvgjzieoa) = qdkmwokkoc xezxodeatm (mybywplvlr ) View more | ||||||
Phase 2 | 9 | bzuafzhbyw(vchssxdobp) = uiyxmmedxe pzurmxvacc (wnbjnnmwuh, mnwzulexpd - ivtvnqbdqy) View more | - | 19 Sep 2024 | |||
Not Applicable | - | zensqxbcuw(agpjjubmsg) = ppacrswrvp zloneooxmt (pxwslizkmr, 9 - 13) | - | 04 Sep 2024 |