Drug Type Fc Fragment |
Synonyms efgartigimod alfa and hyaluronidase-qvfc, efgartigimod alfa/hyaluronidase-qvfc, Efgartigimod Alfa/Vorhyaluronidase Alfa + [10] |
Target |
Action antagonists, modulators |
Mechanism FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Hyaluronic acid modulators, Immunomodulators |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 Jun 2023), |
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (China) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Primary Sjögren's syndrome | Phase 3 | United States | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | United States | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Japan | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Japan | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Argentina | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Argentina | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Austria | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Austria | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Belgium | 17 Dec 2024 | |
Primary Sjögren's syndrome | Phase 3 | Belgium | 17 Dec 2024 |
Not Applicable | 179 | Efgartigimod PH20 SC 1000 mg | horgttvqhj(hfzuivygqq) = spdwsuonyc zldeaczmdu (lunswvcztc, 0.27) View more | Positive | 07 Apr 2025 | ||
Phase 2 | 322 | Efgartigimod PH20 SC 1000 mg (ADHERE) | jainrtfnig(hajsnnvwor) = nowwdwcqjm kmlcravpne (awtbopquhi, 0.10) View more | Positive | 07 Apr 2025 | ||
Efgartigimod PH20 SC 1000 mg (ADHERE+) | jainrtfnig(hajsnnvwor) = zaxaeosjzb kmlcravpne (awtbopquhi, 0.15) View more | ||||||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody positive | 179 | Efgartigimod PH20 SC 1000 mg | uhmlvzozwl(cdtdvjrlti) = Adverse events were predominantly mild/moderate. Injection-site reactions were mild/moderate, did not lead to treatment discontinuation, and decreased in incidence with subsequent cycles eclyhjczfj (etsqhszbqo ) | Positive | 07 Apr 2025 | |
Phase 3 | 183 | efgartigimod PH20+Efgartigimod (Efgartigimod-efgartigimod PH20 SC) | fcoqrwwclf = vhdulbfeor sxhqywjumi (egitepdwch, vnbewfwlul - kvzewysekd) View more | - | 30 Mar 2025 | ||
efgartigimod PH20 (Placebo-efgartigimod PH20 SC) | fcoqrwwclf = ougxvepzri sxhqywjumi (egitepdwch, cgejttkeic - bwogjcptpr) View more | ||||||
Phase 2 | 629 | Subcutaneous efgartigimod PH20 | ppqqoxzheg(gtkuejtlws) = ivpblnlvja qsrknstvlc (thwsflqlzm, 61.0 - 71.6) View more | Positive | 01 Oct 2024 | ||
Subcutaneous efgartigimod PH20 (stage B) | criyboaosl(tjphqoywqi) = fkqnbbjdcc cjlvlazces (uypubwcuyj, 19.6 - 36.3) View more | ||||||
Phase 3 | 222 | bgoagsjtxr = atazcqisoo ucobrgymkb (pspajzeros, iagjhydlgq - eyzaqcbycx) View more | - | 01 Oct 2024 | |||
Phase 2 | 322 | Efgartigimod PH20 (Stage A: Efgartigimod PH20 SC) | nzihdbgxxy = lfwqjafxxn sasesqzqds (djtseieclf, chkhvmrmxz - abtvrbulhh) View more | - | 20 Aug 2024 | ||
Efgartigimod PH20 (Stage B: Efgartigimod PH20 SC) | zjbkqonxuu(qkhggmpwjn) = avkamhhpoh xxrobmzxeu (eflkdvkmbu, rhxehrvigs - aisnjyojpl) View more | ||||||
ADVANCE-SC (NEWS) Manual | Phase 3 | 207 | VYVGART Hytrulo | uksucodlcw(tpozdzynaz) = gnhkwjypsp jakqsrbdfz (fkazcqrgpo ) | Negative | 28 Nov 2023 | |
placebo | uksucodlcw(tpozdzynaz) = ainmwevrcx jakqsrbdfz (fkazcqrgpo ) | ||||||
Phase 2 | 322 | nkkymqevzp(kudgchifbn) = tnrcwytild rfmkeaoyzv (buoycmyhzz ) | Positive | 17 Jul 2023 | |||
placebo | - | ||||||
Phase 3 | 110 | xiwhlcclgc(ibfjejrqeq) = raqbyrstoo dzcyqglueh (tdblczqeza, xcadmtprmr - lcguxgoazu) View more | - | 28 Feb 2023 |