somatrogon

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Stem definition	Drug id	CAS RN
growth hormone derivatives	5517	1663481-09-1

Stem definition

Drug id

CAS RN

growth hormone derivatives

5517

1663481-09-1

Description:

Molecule	Description
Molfile Synonyms: somatrogon ngenla MOD-4023 somatrogon (genetical recombination)	Somatrogon is a glycoprotein comprised of the amino acid sequence of hGH with one copy of the of C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of somatrogon, which allows for weekly dosing. Somatrogon binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Consistent with GH signalling, somatrogon binding leads to activation of the STAT5b signalling pathway and increases the serum concentration of IGF-1. IGF-1 was found to increase in a dose-dependent manner during treatment with somatrogon partially mediating the clinical effect. As a result, GH and IGF-1 stimulate metabolic changes, linear growth and enhance growth velocity in paediatric patients with GHD. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

somatrogon
ngenla
MOD-4023
somatrogon (genetical recombination)

Somatrogon is a glycoprotein comprised of the amino acid sequence of hGH with one copy of the of C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of somatrogon, which allows for weekly dosing. Somatrogon binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Consistent with GH signalling, somatrogon binding leads to activation of the STAT5b signalling pathway and increases the serum concentration of IGF-1. IGF-1 was found to increase in a dose-dependent manner during treatment with somatrogon partially mediating the clinical effect. As a result, GH and IGF-1 stimulate metabolic changes, linear growth and enhance growth velocity in paediatric patients with GHD.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Date	Agency	Company
Feb. 14, 2022	EMA	PFIZER EUROPE MA EEIG
Jan. 20, 2022	PMDA	PFIZER JAPAN INC.
June 27, 2023	FDA	PFIZER IRELAND PHARMACEUTICALS

Date

Agency

Company

Orphan

Feb. 14, 2022

EMA

PFIZER EUROPE MA EEIG

Jan. 20, 2022

PMDA

PFIZER JAPAN INC.

June 27, 2023

FDA

PFIZER IRELAND PHARMACEUTICALS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Injection site pain	694.34	131.70	137	102	173562	90454646

MedDRA adverse event term

Likelihood ratio

Likelihood ratio threshold

Patients taking drug having adverse event

Patients taking drug not having adverse event

Patients not taking drug having adverse event

Patients not taking drug not having adverse event

Injection site pain

694.34

131.70

137

102

173562

90454646

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Injection site pain	1196.08	145.76	230	236	57568	42563301

MedDRA adverse event term

Likelihood ratio

Likelihood ratio threshold

Patients taking drug having adverse event

Patients taking drug not having adverse event

Patients not taking drug having adverse event

Patients not taking drug not having adverse event

Injection site pain

1196.08

145.76

230

236

57568

42563301

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Injection site pain	1499.48	97.81	307	386	177615	110410991

MedDRA adverse event term

Likelihood ratio

Likelihood ratio threshold

Patients taking drug having adverse event

Patients taking drug not having adverse event

Patients not taking drug having adverse event

Patients not taking drug not having adverse event

Injection site pain

1499.48

97.81

307

386

177615

110410991

Source	Code	Description
ATC	H01AC08	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES Somatropin and somatropin agonists

Source

Code

Description

ATC

H01AC08

SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
Somatropin and somatropin agonists

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Growth hormone deficiency	indication	397827003
Acute respiratory failure	contraindication	65710008	DOID:11162
Active intracranial tumours	contraindication	254935002
Multiple accidental trauma	contraindication	1163387009
Children with closed epiphyses	contraindication
Complications following open heart surgery	contraindication
Complications following abdominal surgery	contraindication
Tumour growth	contraindication

Disease

Relation

SNOMED_ID

DOID

Growth hormone deficiency

indication

397827003

Acute respiratory failure

contraindication

65710008

DOID:11162

Active intracranial tumours

contraindication

254935002

Multiple accidental trauma

contraindication

1163387009

Children with closed epiphyses

contraindication

Complications following open heart surgery

contraindication

Complications following abdominal surgery

contraindication

Tumour growth

contraindication

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Growth hormone receptor	Membrane receptor	P10912	GHR_HUMAN	AGONIST	Kd	8.20		SCIENTIFIC LITERATURE	DRUG LABEL
Growth hormone receptor, GH receptor	Membrane receptor		GHR_RAT	AGONIST	Kd	8.29		IUPHAR

Target

Class

Pharos

UniProt

Action

Type

Activity value
(-log[M])

Mechanism
action

Bioact source

MoA source

Growth hormone receptor

Membrane receptor

P10912

GHR_HUMAN

AGONIST

8.20

SCIENTIFIC LITERATURE

DRUG LABEL

Growth hormone receptor, GH receptor

Membrane receptor

GHR_RAT

AGONIST

8.29

IUPHAR

External reference:

ID	Source
CHEBI:757274	CHEBI
CHEMBL4297830	ChEMBL_ID
C000634267	MESH_SUPPLEMENTAL_RECORD_UI
12013	IUPHAR_LIGAND_ID
DB14960	DRUGBANK_ID
1340302009	SNOMEDCT_US
4042462	VANDF
C4726772	UMLSCUI
10402	INN_ID
358066	MMSL
d09873	MMSL
6D848RA61B	UNII
2644503	RXNORM

Source

CHEBI:757274

CHEBI

CHEMBL4297830

ChEMBL_ID

C000634267

MESH_SUPPLEMENTAL_RECORD_UI

12013

IUPHAR_LIGAND_ID

DB14960

DRUGBANK_ID

1340302009

SNOMEDCT_US

4042462

VANDF

C4726772

UMLSCUI

10402

INN_ID

358066

MMSL

d09873

MMSL

6D848RA61B

UNII

2644503

RXNORM

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ngenla	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0505	INJECTION, SOLUTION	24 mg	SUBCUTANEOUS	BLA	31 sections
Ngenla	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0520	INJECTION, SOLUTION	60 mg	SUBCUTANEOUS	BLA	31 sections

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somatrogon 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: