Somapacitan

Summary

Somapacitan (CHEMBL3707290) is an approved small molecule (ATC H01AC07); indicated across 1 condition including pituitary dwarfism.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: H01AC07
• Indications: 1 condition
• Clinical trials: 20
• Chemistry: 1308.6 Da · C55H97N13O19S2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3707290
Name	Somapacitan
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	122197536
ATC	H01AC07
Molecular formula	C55H97N13O19S2
Molecular weight	1308.6
InChIKey	NAKSIOUBFDBTSW-ITMZJIMRSA-N

SMILES: C=C(CCCCCCCCCCCCCCCC1=NNN=N1)NS(=O)(=O)CCCC(=O)NCCOCCOCC(=O)N[C@@H](CCC(=O)N[C@@H](CCC(=O)NCCOCCOCC(=O)N[C@@H](CCCCNC(=O)CSC[C@@H](C(=O)O)N)C(=O)N)C(=O)O)C(=O)O

IUPAC name: (2S)-5-[2-[2-[2-[[(2S)-1-amino-6-[[2-[(2R)-2-amino-2-carboxyethyl]sulfanylacetyl]amino]-1-oxohexan-2-yl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-[[(4S)-4-carboxy-4-[[2-[2-[2-[4-[17-(2H-tetrazol-5-yl)heptadec-1-en-2-ylsulfamoyl]butanoylamino]ethoxy]ethoxy]acetyl]amino]butanoyl]amino]-5-oxopentanoic acid

Also known as: NN-8640, NN8640, NNC-01950092, NNC01950092, Somapacitan, Somapacitan beco, Somapacitan-beco, Sogroya, SOMAPACITAN, Somapacitin-beco

Patent coverage: 65 distinct patent families (153 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 indication (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
pituitary dwarfism	4	MONDO:0006909	EFO:1001109

Clinical trials

Total trials: 20.

Phase distribution

Phase	Trials
PHASE3	7
PHASE1	7
Not specified	4
PHASE2	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05330325	PHASE3	ACTIVE_NOT_RECRUITING	A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
NCT05723835	PHASE3	ACTIVE_NOT_RECRUITING	A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
NCT02229851	PHASE3	COMPLETED	Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
NCT02382939	PHASE3	COMPLETED	A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
NCT03075644	PHASE3	COMPLETED	A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
NCT03811535	PHASE3	COMPLETED	A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
NCT04970654	PHASE3	COMPLETED	A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
NCT03878446	PHASE2	ACTIVE_NOT_RECRUITING	A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
NCT02616562	PHASE2	COMPLETED	Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
NCT01514500	PHASE1	COMPLETED	First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
NCT01706783	PHASE1	COMPLETED	A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
NCT01973244	PHASE1	COMPLETED	A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
NCT02962440	PHASE1	COMPLETED	A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
NCT03186495	PHASE1	COMPLETED	Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
NCT03212131	PHASE1	COMPLETED	Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
NCT03905850	PHASE1	COMPLETED	A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
NCT05230550	Not specified	ACTIVE_NOT_RECRUITING	Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
NCT05718570	Not specified	ENROLLING_BY_INVITATION	A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
NCT06109935	Not specified	ENROLLING_BY_INVITATION	Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
NCT06709040	Not specified	ENROLLING_BY_INVITATION	A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).