New Drug Approvals

WORLD RECORD VIEWS holder on THIS BLOG, ………live, by DR ANTHONY MELVIN CRASTO, Worldpeaceambassador, Worlddrugtracker, Helping millions, 100 million hits on google, pushing boundaries,2.5 lakh plus connections worldwide, 45 lakh plus VIEWS on this blog in 227 countries, 7 CONTINENTS ……A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair, [THIS BLOG HOLDS WORLD RECORD VIEWS ]

New Drug Approvals

Home » APPROVALS 2023 » Zilucoplan

Zilucoplan

Recent Posts

Aficamten December 28, 2025
Zoliflodacin December 26, 2025
Iscartrelvir December 25, 2025
Zoracopan December 24, 2025
Zopocianine December 23, 2025
Zomiradomide December 22, 2025
Zerencotrep December 21, 2025
Zemprocitinib December 20, 2025
Zemirciclib December 19, 2025
Zelenirstat December 18, 2025

Zilucoplan

CAS 1841136-73-9

YG391PK0CC, RA101495, WHO 10602

3562 g/mol, C₁₇₂H₂₇₈N₂₄O₅₅

Zilucoplan lso designated as RA101495, is the active principle of Zilbrysq^®, commercialized by UCB Pharma S.A. It is a 3.5 kDa synthetic macrocyclic peptide composed of 15 amino acid residues, including four unnatural amino acids [27]. The amino acid residues composition is: L-Lys, L-Val, L-Glu, L-Arg, L-Phe, L-Asp, L-L-NMe-Asp, L-tButyl-Gly, L-Tyr, L-7-aza-Trp, L-Glu, L-Tyr, L-Pro, L-Cyclohexyl-Gly, and L-Lys.

N2-ACETYL-L-LYSYL-L-VALYL-L-.ALPHA.-GLUTAMYL-L-ARGINYL-L-PHENYLALANYL-L-.ALPHA.-ASPARTYL-N-METHYL-L-.ALPHA.-ASPARTYL-3-METHYL-L-VALYL-L-TYROSYL-3-(1H-PYRROLO(2,3-B)PYRIDIN-3-YL)-L-ALANYL-L-.ALPHA.-GLUTAMYL-L-TYROSYL-L-PROLYL-(2S)-2-CYCLOHEXYLGLYCYL-N6-(3

POLY(OXY-1,2-ETHANEDIYL), ALPHA-(2-(((4S)-4-CARBOXY-1-OXO-4-(1-OXOHEXADECYL)BUTYL)AMINO)ETHYL)-OMEGA-HYDROXY-, 15-ETHER WITH N-ACETYL-L-LYSYL-L-VALYL-L-ALPHA-GLUTAMYL-L-ARGINYL-L-PHENYLALANYL-L-ALPHA-ASPARTYL-N-METHYL-L-ALPHA-ASPARTYL-3-METHYL-

(2s)-2-(((2s)-2-(((2s)-1-((2s)-2-(((2s)-2-(((2s)-2-(((2s)-2-(((2s)-2-(((2s)-2-(((2s,5s,8s,11s,14s,22s)-22-acetamido-11-benzyl-8-(3-carbamimidamidopropyl)-5-(2-carboxyethyl)-3,6,9,12,16,23-hexaoxo-2-propan-2-yl-1,4,7,10,13,17-hexazacyclotricosane-14-carbonyl)-methylamino)-3-carboxypropanoyl)amino)-3,3-dimethylbutanoyl)amino)-3-(4-hydroxyphenyl)propanoyl)amino)-3-(1h-pyrrolo(2,3-b)pyridin-3-yl)propanoyl)amino)-4-carboxybutanoyl)amino)-3-(4-hydroxyphenyl)propanoyl)pyrrolidine-2-carbonyl)amino)-2-cyclohexylacetyl)amino)-6-(3-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(2-(((4s)-4-carboxy-4-(hexadecanoylamino)butanoyl)amino)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)propanoylamino)hexanoic acid

(2s)-2-[[(2s)-2-[[(2s)-1-[(2s)-2-[[(2s)-2-[[(2s)-2-[[(2s)-2-[[(2s)-2-[[(2s)-2-[[(2s,5s,8s,11s,14s,22s)-22-acetamido-11-benzyl-8-(3-carbamimidamidopropyl)-5-(2-carboxyethyl)-3,6,9,12,16,23-hexaoxo-2-propan-2-yl-1,4,7,10,13,17-hexazacyclotricosane-14-carbonyl]-methylamino]-3-carboxypropanoyl]amino]-3,3-dimethylbutanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-(1h-pyrrolo[2,3-b]pyridin-3-yl)propanoyl]amino]-4-carboxybutanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]pyrrolidine-2-carbonyl]amino]-2-cyclohexylacetyl]amino]-6-[3-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[[(4s)-4-carboxy-4-(hexadecanoylamino)butanoyl]amino]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]propanoylamino]hexanoic acid

(2S)-2-[[(2S)-2-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,5S,8S,11S,14S,22S)-22-acetamido-11-benzyl-8-(3-carbamimidamidopropyl)-5-(2-carboxyethyl)-3,6,9,12,16,23-hexaoxo-2-propan-2-yl-1,4,7,10,13,17-hexazacyclotricosane-14-carbonyl]-methylamino]-3-carboxypropanoyl]amino]-3,3-dimethylbutanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-(1H-pyrrolo[2,3-b]pyridin-3-yl)propanoyl]amino]-4-carboxybutanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]pyrrolidine-2-carbonyl]amino]-2-cyclohexylacetyl]amino]-6-[3-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[[(4S)-4-carboxy-4-(hexadecanoylamino)butanoyl]amino]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]propanoylamino]hexanoic acid

Ingredient	UNII	CAS	InChI Key
Zilucoplan Sodium	Not Available	Not Available	FUSMWKLQHKXKHI-WHKBRXDJSA-J

FDA 10/17/2023, Zilbrysq, To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
Drug Trials Snapshot

Zilucoplan, sold under the brand name Zilbrysq, is a medication used for the treatment of generalized myasthenia gravis.^[6]^[9]^[10] It is a complement inhibitor that is injected subcutaneously (under the skin).^[6]

Zilucoplan is a cyclic peptide that binds to the protein complement component 5 (C5) and inhibits its cleavage into C5a and C5b.^[11]

Zilucoplan was approved for medical use in the United States in October 2023,^[6]^[12] in the European Union in December 2023,^[7] and in Australia in July 2024.^[1]

Zilucoplan is a 15 amino-acid, synthetic macrocyclic peptide with formula C172H278N24O55. Its sodium salt is used for the treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) in adults whose immune system produces antibodies against acetylcholine receptors. It has a role as a complement component 5 inhibitor and an immunosuppressive agent. It is a macrocycle, a homodetic cyclic peptide and a polyether. It is a conjugate acid of a zilucoplan(4-).

PATENT

Patent Number	Pediatric Extension	Approved	Expires (estimated)
US11752190	No	2023-09-12	2035-06-12
US11014965	No	2021-05-25	2035-06-12
US10435438	No	2019-10-08	2035-06-12
US10208089	No	2019-02-19	2035-06-12
US10106579	No	2018-10-23	2035-06-12
US10835574	No	2020-11-17	2035-06-12
US11535650	No	2022-12-27	2035-06-12
US10562934	No	2020-02-18	2035-06-12
US11965040	No	2024-04-23	2035-06-12

PAPER

https://www.mdpi.com/2813-2998/3/2/18

References

^ Jump up to:^a ^b ^c “Zilbrysq (zilucoplan)”. Therapeutic Goods Administration (TGA). 24 September 2024. Retrieved 12 October 2024.
^ “Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024”. Federal Register of Legislation. 30 May 2024. Retrieved 10 June 2024.
^ “Zilbrysq (UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia)”. Therapeutic Goods Administration (TGA). 13 September 2024. Retrieved 15 September 2024.
^ “Notice: Multiple additions to the Prescription Drug List (PDL) [2024-08-13]”. Health Canada. 13 August 2024. Retrieved 15 August 2024.
^ “Regulatory Decision Summary for Zilbrysq”. Drug and Health Products Portal. 11 July 2024. Retrieved 27 December 2024.
^ Jump up to:^a ^b ^c ^d ^e “Zilbrysq- zilucoplan injection, solution”. DailyMed. 19 July 2024. Retrieved 15 September 2024.
^ Jump up to:^a ^b ^c ^d “Zilbrysq EPAR”. European Medicines Agency. 1 December 2023. Retrieved 11 December 2023.
^ “Zilbrysq Product information”. Union Register of medicinal products. 4 December 2023. Archived from the original on 11 December 2023. Retrieved 11 December 2023.
^ Howard JF, Kaminski HJ, Nowak RJ, Wolfe GI, Benatar MG, Ricardo A, et al. (April 2018). “RA101495, a subcutaneously administered peptide inhibitor of complement component 5 (C5) for the treatment of generalized myasthenia gravis (gMG): Phase 1 results and phase 2 design (S31. 006)”. Neurology. 90 (15 Supplement). doi:10.1212/WNL.90.15_supplement.S31.006. S2CID 56969245. Archived from the original on 22 February 2022. Retrieved 24 June 2021.
^ Howard JF, Vissing J, Gilhus NE, Leite MI, Utsugisawa K, Duda PW, et al. (May 2021). “Zilucoplan: An Investigational Complement C5 Inhibitor for the Treatment of Acetylcholine Receptor Autoantibody-Positive Generalized Myasthenia Gravis”. Expert Opinion on Investigational Drugs. 30 (5): 483–493. doi:10.1080/13543784.2021.1897567. hdl:11250/2770699. PMID 33792453. S2CID 232482753.
^ Ricardo A, Arata M, DeMarco S, Dhamnaskar K, Hammer R, Fridkis-Hareli M, et al. (2015). “Preclinical Evaluation of RA101495, a Potent Cyclic Peptide Inhibitor of C5 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria”. Blood. 126 (23): 939. doi:10.1182/blood.V126.23.939.939.
^ “Novel Drug Approvals for 2023”. U.S. Food and Drug Administration (FDA). 22 December 2023. Archived from the original on 8 January 2023. Retrieved 27 December 2023.
^ Jump up to:^a ^b “Zilbrysq: Pending EC decision”. European Medicines Agency. 15 September 2023. Archived from the original on 26 September 2023. Retrieved 24 September 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ “Zilucoplan Orphan Drug Designations and Approvals”. U.S. Food and Drug Administration (FDA). Archived from the original on 17 October 2023. Retrieved 19 October 2023.
^ “EU/3/22/2650: Orphan designation for the treatment of myasthenia gravis”. European Medicines Agency. 15 September 2023. Archived from the original on 29 January 2023. Retrieved 24 September 2023.
^ World Health Organization (2018). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80”. WHO Drug Information. 32 (3). hdl:10665/330907.

External links

Clinical trial number NCT04115293 for “Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE)” at ClinicalTrials.gov

Clinical data

Trade names	Zilbrysq
Other names	RA101495
AHFS/Drugs.com	Monograph
MedlinePlus	a624002
License data	US DailyMed: Zilucoplan
Pregnancy category	AU: D^[1]
Routes of administration	Subcutaneous
Drug class	Complement inhibitor
ATC code	L04AJ06 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)^[2]^[3]^[1]CA: ℞-only^[4]^[5]US: ℞-only^[6]EU: Rx-only^[7]^[8]
Identifiers
showIUPAC name
CAS Number	1841136-73-9
PubChem CID	133083018
DrugBank	DB15636
ChemSpider	71115966
UNII	YG391PK0CC
KEGG	D12357
ChEBI	CHEBI:229659
Chemical and physical data
Formula	C₁₇₂H₂₇₈N₂₄O₅₅
Molar mass	3562.229 g·mol⁻¹
3D model (JSmol)	Interactive image
showSMILES
showInChI

/////////zilucoplan, Zilbrysq, FDA 2023, APPROVALS 2023, EU 2023, EMA 2023, RA101495, RA 101495, WHO 10602

Tags: APPROVALS 2023, EMA 2023, EU 2023, FDA 2023, RA 101495, RA101495, Zilbrysq

By DR ANTHONY MELVIN CRASTO Ph.D in APPROVALS 2023, EU 2023, FDA 2023 on June 16, 2025.

Latest Posts

Aficamten
Aficamten C18H19N5O2, 337.4 g/mol FDA 2025, APPROVALS 2025, Myqorzo, 12/19/2025, To treat symptomatic obstructive hypertrophic cardiomyopathy CK-3773274, B1I77MH6K1, BAY-3723113; CK 3773274; CK 274; MYQORZO N-[(1R)-5-(5-ethyl-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1H-inden-1-yl]-1-methylpyrazole-4-carboxamide Aficamten,…
Zoliflodacin
Zoliflodacin MF C22H22FN5O7 MW 487.4 g/mol FDA 2025, APPROVALS 2025, 12/12/2025, Nuzolvence (4′R,6′S,7′S)-17′-fluoro-4′,6′-dimethyl-13′-[(4S)-4-methyl-2-oxo-1,3-oxazolidin-3-yl]spiro[1,3-diazinane-5,8′-5,15-dioxa-2,14-diazatetracyclo[8.7.0.02,7.012,16]heptadeca-1(17),10,12(16),13-tetraene]-2,4,6-trione Spiro[isoxazolo[4,5-g][1,4]oxazino[4,3-a]quinoline-5(6H),5′(2′H)-pyrimidine]-2′,4′,6′(1′H,3′H)-trione, 11-fluoro-1,2,4,4a-tetrahydro-2,4-dimethyl-8-[(4S)-4-methyl-2-oxo-3-oxazolidinyl]-, (2R,4S,4aS)- (2R,4S,4aS)-11-Fluoro-2,4-dimethyl-8-[(4S)-4-methyl-2-oxo-1,3-oxazolidin-3-yl]-1,2,4,4a-tetrahydro-2′H,6H-spiro[1,4-oxazino[4,3-a][1,2]oxazolo[4,5-g]quinoline-5,5′-pyrimidine]-2′,4′,6′(1′H,3′H)-trione To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae…
Iscartrelvir
Iscartrelvir CAS 2921711-74-0 MF 2921711-74-0, 526.4 g/mol N-{(1S,2R)-2-[4-bromo-2-(methylcarbamoyl)-6-nitroanilino]cyclohexyl}isoquinoline-4-carboxamideantiviral, WU-04, WU 04, W2LTV65R5E Iscartrelvir is an investigational new drug developed by the Westlake University for the treatment of COVID-19. It targets the SARS-CoV-2 3CL…
Zoracopan
Zoracopan CAS 2243483-63-6 MF C31H31BrN6O3 MW 615.52 2-Azabicyclo[3.1.0]hexane-3-carboxamide, 2-[2-[3-acetyl-7-methyl-5-(2-methyl-5-pyrimidinyl)-1H-indol-1-yl]acetyl]-N-(6-bromo-3-methyl-2-pyridinyl)-5-methyl-, (1R,3S,5R)- (1R,3S,5R)-2-{[3-acetyl-7-methyl-5-(2-methylpyrimidin5-yl)-1H-indol-1-yl]acetyl}-N-(6-bromo-3-methylpyridin2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamidecomplement factor D inhibitor, ALXN-2080, ALXN 2080, E7799Y8LXY Zoracopan is a selective complement factor D (CFD) inhibitor.…

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

View Full Profile →

Blog at WordPress.com.

	shivkr2 on SPSR Excellence Award 2025 – S…
	Bonkasaurus on Infigratinib phosphate
	PALOVAROTENE \| ORGAN… on Palovarotene
	Pfizer just purchase… on Temanogrel
	Pfizer To Cash In On… on Temanogrel
	VÍDEOS – A Pfizer ac… on Temanogrel
	Pfizer Bought Arena… on Temanogrel
	Pfizer va profita de… on Temanogrel
	Pfizer to Cash In on… on Temanogrel
	Pfizer tocmai a achi… on Temanogrel
	Pfizer just purchase… on Temanogrel
	Pfizer just purchase… on Temanogrel
	Tanya A on Dasotraline, ダソトラリン
	Julia Chernus on RIDINILAZOLE
	Adv.Siji Antony Kera… on Myself Anthony Crasto up for g…

	shivkr2 on SPSR Excellence Award 2025 – S…
	Bonkasaurus on Infigratinib phosphate
	PALOVAROTENE \| ORGAN… on Palovarotene
	Pfizer just purchase… on Temanogrel
	Pfizer To Cash In On… on Temanogrel
	VÍDEOS – A Pfizer ac… on Temanogrel
	Pfizer Bought Arena… on Temanogrel
	Pfizer va profita de… on Temanogrel
	Pfizer to Cash In on… on Temanogrel
	Pfizer tocmai a achi… on Temanogrel
	Pfizer just purchase… on Temanogrel
	Pfizer just purchase… on Temanogrel
	Tanya A on Dasotraline, ダソトラリン
	Julia Chernus on RIDINILAZOLE
	Adv.Siji Antony Kera… on Myself Anthony Crasto up for g…

New Drug Approvals

Zilucoplan

SEARCH THIS BLOG

ORGANIC SPECTROSCOPY

Meta

Pages

Archives