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Chemistry

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Also known as: Voxzogo, Bmn 111, Bmn-111, Vosoritide [usan:inn], Unii-7se5582q2p, 1480724-61-5
Molecular Formula
C176H290N56O51S3
Molecular Weight
4103  g/mol
InChI Key
IGYWDDBBJPSOTG-WBAGYEQSSA-N

Vosoritide
Achondroplasia is an autosomal dominant genetic disease and the most common cause of dwarfism in humans. It results from a gain-of-function missense mutation in FGFR3 that results in a dramatic suppression of bone growth, both in volume and in length. Treatment for achondroplasia includes both surgical and pharmacological interventions, the latter of which includes C-type natriuretic peptide (CNP) analogs. Endogenous CNP, first described in 1998, is primarily responsible for the stimulation of chondrocytes and long bone growth via activity at the NPR-B receptor, making it an attractive target in the treatment of a condition like achondroplasia. While the remarkably short half-life of endogenous CNP - 2 to 3 minutes due to its rapid degradation by endopeptidases - makes it ineffective as a therapeutic intervention, the development of a peptidase-resistant formulation has allowed for its use as a viable treatment option in achondroplasia. Vosoritide is an analog of CNP with proline-glycine on its N-terminus to convey resistance to neutral endopeptidase. It was approved for use under the brand name Voxzogo (BioMarin Pharmaceutical Inc.) in the EU in August 2021 and the US in November 2021, becoming the first pharmacological intervention approved for the treatment of achondroplasia in both regions.
1 2D Structure

Vosoritide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,10S,16S,19S,22S,28S,31S,34S,37S,40S,43S,49S,52R)-52-[[2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-6-amino-2-[[(2S)-6-amino-2-[[(2S)-4-amino-2-[[(2S)-2-[[2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S)-5-amino-5-oxo-2-[[2-[[(2S)-pyrrolidine-2-carbonyl]amino]acetyl]amino]pentanoyl]amino]-4-carboxybutanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]pyrrolidine-2-carbonyl]amino]-4-oxobutanoyl]amino]propanoyl]amino]-5-carbamimidamidopentanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]hexanoyl]amino]acetyl]amino]propanoyl]amino]-4-oxobutanoyl]amino]hexanoyl]amino]hexanoyl]amino]acetyl]amino]-4-methylpentanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]acetyl]amino]-40-(4-aminobutyl)-49-benzyl-28-[(2S)-butan-2-yl]-31-(3-carbamimidamidopropyl)-34-(carboxymethyl)-16,22-bis(hydroxymethyl)-10,37,43-tris(2-methylpropyl)-19-(2-methylsulfanylethyl)-6,9,12,15,18,21,24,27,30,33,36,39,42,45,48,51-hexadecaoxo-1,2-dithia-5,8,11,14,17,20,23,26,29,32,35,38,41,44,47,50-hexadecazacyclotripentacontane-4-carboxylic acid
2.1.2 InChI
InChI=1S/C176H290N56O51S3/c1-14-95(10)143-172(280)201-84-138(245)209-125(86-234)168(276)221-113(54-65-284-13)159(267)229-124(85-233)152(260)200-81-135(242)206-114(66-91(2)3)150(258)198-83-140(247)211-128(174(282)283)89-286-285-88-127(170(278)224-118(70-98-34-16-15-17-35-98)151(259)199-80-137(244)207-115(67-92(4)5)162(270)217-108(41-23-29-60-182)155(263)223-117(69-94(8)9)164(272)226-122(75-142(250)251)167(275)219-110(160(268)231-143)44-32-63-193-176(188)189)210-139(246)82-197-149(257)105(38-20-26-57-179)215-169(277)126(87-235)230-163(271)116(68-93(6)7)208-136(243)79-196-147(255)103(36-18-24-55-177)213-153(261)106(39-21-27-58-180)218-166(274)121(74-132(185)239)222-144(252)96(11)203-133(240)77-195-148(256)104(37-19-25-56-178)214-165(273)119(71-99-46-48-101(236)49-47-99)225-156(264)107(40-22-28-59-181)216-154(262)109(43-31-62-192-175(186)187)212-145(253)97(12)204-161(269)120(73-131(184)238)227-171(279)129-45-33-64-232(129)173(281)123(72-100-76-190-90-202-100)228-158(266)112(51-53-141(248)249)220-157(265)111(50-52-130(183)237)205-134(241)78-194-146(254)102-42-30-61-191-102/h15-17,34-35,46-49,76,90-97,102-129,143,191,233-236H,14,18-33,36-45,50-75,77-89,177-182H2,1-13H3,(H2,183,237)(H2,184,238)(H2,185,239)(H,190,202)(H,194,254)(H,195,256)(H,196,255)(H,197,257)(H,198,258)(H,199,259)(H,200,260)(H,201,280)(H,203,240)(H,204,269)(H,205,241)(H,206,242)(H,207,244)(H,208,243)(H,209,245)(H,210,246)(H,211,247)(H,212,253)(H,213,261)(H,214,273)(H,215,277)(H,216,262)(H,217,270)(H,218,274)(H,219,275)(H,220,265)(H,221,276)(H,222,252)(H,223,263)(H,224,278)(H,225,264)(H,226,272)(H,227,279)(H,228,266)(H,229,267)(H,230,271)(H,231,268)(H,248,249)(H,250,251)(H,282,283)(H4,186,187,192)(H4,188,189,193)/t95-,96-,97-,102-,103-,104-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,143-/m0/s1
2.1.3 InChI Key
IGYWDDBBJPSOTG-WBAGYEQSSA-N
2.1.4 Canonical SMILES
CCC(C)C1C(=O)NCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NCC(=O)NC(C(=O)NCC(=O)NC(CSSCC(C(=O)NC(C(=O)NCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N1)CCCNC(=N)N)CC(=O)O)CC(C)C)CCCCN)CC(C)C)CC2=CC=CC=C2)NC(=O)CNC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CCCCN)NC(=O)C(CCCCN)NC(=O)C(CC(=O)N)NC(=O)C(C)NC(=O)CNC(=O)C(CCCCN)NC(=O)C(CC3=CC=C(C=C3)O)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)C(C)NC(=O)C(CC(=O)N)NC(=O)C4CCCN4C(=O)C(CC5=CN=CN5)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)N)NC(=O)CNC(=O)C6CCCN6)C(=O)O)CC(C)C)CO)CCSC)CO
2.1.5 Isomeric SMILES
CC[C@H](C)[C@H]1C(=O)NCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)NCC(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)NCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CCCNC(=N)N)CC(=O)O)CC(C)C)CCCCN)CC(C)C)CC2=CC=CC=C2)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](CC3=CC=C(C=C3)O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C)NC(=O)[C@H](CC(=O)N)NC(=O)[C@@H]4CCCN4C(=O)[C@H](CC5=CN=CN5)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)N)NC(=O)CNC(=O)[C@@H]6CCCN6)C(=O)O)CC(C)C)CO)CCSC)CO
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Bmn 111

2. Voxzogo

2.2.2 Depositor-Supplied Synonyms

1. Voxzogo

2. Bmn 111

3. Bmn-111

4. Vosoritide [usan:inn]

5. Unii-7se5582q2p

6. 1480724-61-5

7. Gtpl9068

8. 7se5582q2p

2.3 Create Date
2016-05-29
3 Chemical and Physical Properties
Molecular Weight 4103 g/mol
Molecular Formula C176H290N56O51S3
XLogP3-20.6
Hydrogen Bond Donor Count61
Hydrogen Bond Acceptor Count64
Rotatable Bond Count112
Exact Mass4101.1016174 g/mol
Monoisotopic Mass4100.0982626 g/mol
Topological Polar Surface Area1820 Ų
Heavy Atom Count286
Formal Charge0
Complexity9600
Isotope Atom Count0
Defined Atom Stereocenter Count32
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Vosoritide is indicated for the promotion of linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses.


Voxzogo is indicated for the treatment of achondroplasia in patients 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Vosoritide is an analog of C-type natriuretic peptide that promotes bone growth to combat growth suppression in children with achondroplasia. Urinary cyclic guanosine monophosphate (cGMP) and serum collagen type X marker (CXM) are both elevated following daily therapy with vosoritide and serve as biomarkers for evidence of increased endochondral bone growth, with cGMP indicative of NPR-B binding activity and CXM indicative of bone metabolism. Although relatively well-tolerated, transient episodes of hypotension have been observed in clinical studies. Patients with pre-existing cardiovascular disease and those taking antihypertensive medications were excluded from clinical trials. The risk of hypotension may be reduced by ensuring adequate food and fluid intake prior to the administration of vosoritide. The use of vosoritide in patients with an eGFR <60 mL/min/1.73m2 should also be avoided as there are no data on the influence of renal impairment on its pharmacokinetics.


5.2 ATC Code

M05BX


M - Musculo-skeletal system

M05 - Drugs for treatment of bone diseases

M05B - Drugs affecting bone structure and mineralization

M05BX - Other drugs affecting bone structure and mineralization

M05BX07 - Vosoritide


5.3 Absorption, Distribution and Excretion

Absorption

In patients receiving daily subcutaneous injections of vosoritide 15 mcg/kg, the mean Cmax ranged from 4.71-7.18 ng/mL and the mean AUC0-t ranged from 161-290 ng-min/mL. The median Tmax following subcutaneous injection was approximately 15 minutes.


Volume of Distribution

The mean apparent volume of distribution following the subcutaneous administration of 15 mcg/kg of vosoritide ranged from 2880 to 3020 mL/kg.


Clearance

The mean apparent clearance following the subcutaneous administration of 15 mcg/kg of vosoritide ranged from 79.4 to 104 mL/min/kg.


5.4 Metabolism/Metabolites

As with other therapeutic proteins, vosoritide is likely metabolized via catabolic pathways into smaller peptides and amino acids.


5.5 Biological Half-Life

The mean half-life following the subcutaneous administration of 15 mcg/kg of vosoritide ranged from 21.0 to 27.9 minutes.


5.6 Mechanism of Action

Achondroplasia is a congenital disease resulting from a missense mutation in the fibroblast growth factor receptor 3 (_FGFR3_) gene, resulting in a gain-of-function that negatively regulates endochondral bone growth. Under normal conditions, _FGFR3_ is expressed during both embryonic and postnatal development, but serves a different role in each. During initial development, FGFR3 signaling promotes proliferation of chondrocytes (i.e. growth), whereas postnatal skeletal growth is actually inhibited by FGFR3 - as a result, the pathologic activation of FGFR3 observed in patients with achondroplasia leads to suppressed pre-pubertal skeletal growth. Vosoritide is an analog of C-type natriuretic peptide (CNP), a signaling molecule that appears primarily responsible for the stimulation of chondrocytes and the growth of long bones. The binding of CNP (or vosoritide) with its corresponding receptor, NPR-B, results in a signaling cascade that ultimately inhibits the MAPK/ERK pathway via inhibition of RAF-1 and stimulates the proliferation and differentiation of chondrocytes. This activity serves to antagonize the downstream signaling resulting from FGFR3 and its resultant effects on bone growth.


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Vosoritide

About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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BCN Peptides

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About the Company : BCN Peptides is a privately own company completely focused on the cGMP manufacture of Bioactive Peptides for Pharmaceutical and Veterinary applications. We are a customer oriented...

BCN Peptides is a privately own company completely focused on the cGMP manufacture of Bioactive Peptides for Pharmaceutical and Veterinary applications. We are a customer oriented organization focused on fulfilling the client’s needs at each stage of the their peptide drug development and lifecycle management. It also includes a team of dedicated and passionate scientists which help us to provide to our customer a scientific excellence in terms of synthetic peptide chemistry and analytical expertise. BCN Peptides has an excellent track record of successful inspections by Global Health Agencies (US FDA, EDQM, KFDA,…)
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Drugs in Development

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Details:

Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 20, 2023

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01

ASPEN
Not Confirmed
ASPEN
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Details : Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

October 20, 2023

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Details:

Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 15, 2023

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02

ASPEN
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ASPEN
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Details : Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

September 15, 2023

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Details:

Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 07, 2023

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03

ASPEN
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ASPEN
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Details : Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

March 07, 2023

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Details:

VOXZOGO (Vosoritide) is a prescription medicine used to increase linear growth in children with achondroplasia who are 5 years of age and older with open growth plates (epiphyses).


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 21, 2022

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04

ASPEN
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ASPEN
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Details : VOXZOGO (Vosoritide) is a prescription medicine used to increase linear growth in children with achondroplasia who are 5 years of age and older with open growth plates (epiphyses).

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

June 21, 2022

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Details:

VOXZOGO™ (vosoritide) for Injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses (growth plates).


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Undisclosed

Deal Size: $110.0 million Upfront Cash: Undisclosed

Deal Type: Divestment February 09, 2022

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05

ASPEN
Not Confirmed
ASPEN
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Details : VOXZOGO™ (vosoritide) for Injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses (growth plates).

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Undisclosed

February 09, 2022

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Details:

Voxzogo (vosoritide) a CNP analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 19, 2021

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06

ASPEN
Not Confirmed
ASPEN
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Details : Voxzogo (vosoritide) a CNP analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

November 19, 2021

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Details:

Voxzogo, a modified C-type natriuretic peptide (CNP), directly targets the underlying pathophysiology of achondroplasia by down regulating fibroblast growth factor receptor 3 (FGFR3) signaling and consequently promoting endochondral bone formation.


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2021

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07

ASPEN
Not Confirmed
ASPEN
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Details : Voxzogo, a modified C-type natriuretic peptide (CNP), directly targets the underlying pathophysiology of achondroplasia by down regulating fibroblast growth factor receptor 3 (FGFR3) signaling and consequently promoting endochondral bone formation.

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

August 27, 2021

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Details:

LB-100 has been shown to enhance anti-cancer activity of standard chemotherapy and immunotherapy regimens against a broad spectrum of human cancers in animal models.


Lead Product(s): LB-100,Vosoritide

Therapeutic Area: Genetic Disease Brand Name: LB-100

Study Phase: PreclinicalProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 22, 2021

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ASPEN
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Details : LB-100 has been shown to enhance anti-cancer activity of standard chemotherapy and immunotherapy regimens against a broad spectrum of human cancers in animal models.

Product Name : LB-100

Product Type : Small molecule

Upfront Cash : Not Applicable

July 22, 2021

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Details:

Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO™ (vosoritide).


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: Voxzogo

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 25, 2021

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09

ASPEN
Not Confirmed
ASPEN
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Details : Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO™ (vosoritide).

Product Name : Voxzogo

Product Type : Peptide

Upfront Cash : Not Applicable

June 25, 2021

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Details:

The objectives of the study are to evaluate safety, tolerability, and the effect of vosoritide on growth. Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia.


Lead Product(s): Vosoritide

Therapeutic Area: Genetic Disease Brand Name: BMN 111

Study Phase: Phase IIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 03, 2021

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ASPEN
Not Confirmed
ASPEN
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Details : The objectives of the study are to evaluate safety, tolerability, and the effect of vosoritide on growth. Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia.

Product Name : BMN 111

Product Type : Peptide

Upfront Cash : Not Applicable

March 03, 2021

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VOSORITIDE

Brand Name : VOXZOGO

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 0.4MG/VIAL

Packaging :

Approval Date : 2021-11-19

Application Number : 214938

Regulatory Info : RX

Registration Country : USA

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VOSORITIDE

Brand Name : VOXZOGO

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 0.56MG/VIAL

Packaging :

Approval Date : 2021-11-19

Application Number : 214938

Regulatory Info : RX

Registration Country : USA

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VOSORITIDE

Brand Name : VOXZOGO

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 1.2MG/VIAL

Packaging :

Approval Date : 2021-11-19

Application Number : 214938

Regulatory Info : RX

Registration Country : USA

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vosoritide

Brand Name : Voxzogo

Dosage Form :

Dosage Strength :

Packaging : 10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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ASPEN
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vosoritide

Brand Name : Voxzogo

Dosage Form :

Dosage Strength :

Packaging : 10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

ASPEN
Not Confirmed
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vosoritide

Brand Name : Voxzogo

Dosage Form :

Dosage Strength :

Packaging : 10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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FDA Orange Book

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VOSORITIDE

Brand Name : VOXZOGO

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 0.4MG/VIAL

Approval Date : 2021-11-19

Application Number : 214938

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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VOSORITIDE

Brand Name : VOXZOGO

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 0.56MG/VIAL

Approval Date : 2021-11-19

Application Number : 214938

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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VOSORITIDE

Brand Name : VOXZOGO

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 1.2MG/VIAL

Approval Date : 2021-11-19

Application Number : 214938

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Australia

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vosoritide

Brand Name : Voxzogo

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Packaging : 10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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ASPEN
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ASPEN
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vosoritide

Brand Name : Voxzogo

Dosage Form :

Dosage Strength :

Packaging : 10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

vosoritide

Brand Name : Voxzogo

Dosage Form :

Dosage Strength :

Packaging : 10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Digital Content read-more

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NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/biomarin-to-present-data-underscoring-sustained-positive-impact-of-voxzogo-vosoritide-on-health-related-quality-of-life-growth-and-maintenance-of-bone-strength-in-children-with-achondroplasia-at-2024-international-skeletal-dys-302251087.html

PR NEWSWIRE
18 Sep 2024

https://www.prnewswire.com/news-releases/biomarin-to-present-data-highlighting-significant-impact-of-voxzogo-vosoritide-in-bone-health-and-health-related-quality-of-life-in-achondroplasia-at-2024-international-conference-on-childrens-bone-health-302173608.html

PR NEWSWIRE
17 Jun 2024

https://investors.biomarin.com/news/news-details/2024/New-Data-for-BioMarins-VOXZOGO-vosoritide-for-Multiple-Growth-Related-Conditions-in-Children-Presented-at-Pediatric-Endocrine-Society-PES-Annual-Meeting/default.aspx

PRESS RELEASE
04 May 2024

https://www.prnewswire.com/news-releases/new-data-to-be-presented-for-biomarins-voxzogo-vosoritide-in-children-with-hypochondroplasia-and-achondroplasia-at-the-american-college-of-medical-genetics-and-genomics-acmg-annual-clinical-genetics-meeting-302085829.html

PR NEWSWIRE
12 Mar 2024

https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-biomarins-voxzogo-vosoritide-for-children-under-5-years-with-achondroplasia-301963505.html

PR NEWSWIRE
21 Oct 2023

https://investors.biomarin.com/2023-09-21-BioMarin-to-Present-Data-Showing-Long-Term-Benefit-of-VOXZOGO-R-vosoritide-on-Growth-in-Children-with-Achondroplasia-at-2023-European-Society-for-Paediatric-Endocrinology-ESPE-Meeting

PRESS RELEASE
21 Sep 2023

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ABOUT THIS PAGE

Looking for 1480724-61-5 / Vosoritide API manufacturers, exporters & distributors?

Vosoritide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Vosoritide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vosoritide manufacturer or Vosoritide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vosoritide manufacturer or Vosoritide supplier.

PharmaCompass also assists you with knowing the Vosoritide API Price utilized in the formulation of products. Vosoritide API Price is not always fixed or binding as the Vosoritide Price is obtained through a variety of data sources. The Vosoritide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vosoritide

Synonyms

Voxzogo, Bmn 111, Bmn-111, Vosoritide [usan:inn], Unii-7se5582q2p, 1480724-61-5

Cas Number

1480724-61-5

About Vosoritide

Achondroplasia is an autosomal dominant genetic disease and the most common cause of dwarfism in humans. It results from a gain-of-function missense mutation in FGFR3 that results in a dramatic suppression of bone growth, both in volume and in length. Treatment for achondroplasia includes both surgical and pharmacological interventions, the latter of which includes C-type natriuretic peptide (CNP) analogs. Endogenous CNP, first described in 1998, is primarily responsible for the stimulation of chondrocytes and long bone growth via activity at the NPR-B receptor, making it an attractive target in the treatment of a condition like achondroplasia. While the remarkably short half-life of endogenous CNP - 2 to 3 minutes due to its rapid degradation by endopeptidases - makes it ineffective as a therapeutic intervention, the development of a peptidase-resistant formulation has allowed for its use as a viable treatment option in achondroplasia. Vosoritide is an analog of CNP with proline-glycine on its N-terminus to convey resistance to neutral endopeptidase. It was approved for use under the brand name Voxzogo (BioMarin Pharmaceutical Inc.) in the EU in August 2021 and the US in November 2021, becoming the first pharmacological intervention approved for the treatment of achondroplasia in both regions.

Vosoritide Manufacturers

A Vosoritide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vosoritide, including repackagers and relabelers. The FDA regulates Vosoritide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vosoritide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Vosoritide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vosoritide Suppliers

A Vosoritide supplier is an individual or a company that provides Vosoritide active pharmaceutical ingredient (API) or Vosoritide finished formulations upon request. The Vosoritide suppliers may include Vosoritide API manufacturers, exporters, distributors and traders.

click here to find a list of Vosoritide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vosoritide GMP

Vosoritide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Vosoritide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vosoritide GMP manufacturer or Vosoritide GMP API supplier for your needs.

Vosoritide CoA

A Vosoritide CoA (Certificate of Analysis) is a formal document that attests to Vosoritide's compliance with Vosoritide specifications and serves as a tool for batch-level quality control.

Vosoritide CoA mostly includes findings from lab analyses of a specific batch. For each Vosoritide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Vosoritide may be tested according to a variety of international standards, such as European Pharmacopoeia (Vosoritide EP), Vosoritide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vosoritide USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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