Thalidomide

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Thalidomide is an ofp drug catalogued in DrugCentral. It was first approved by the FDA in 1998. DrugCentral lists 7 molecular targets, including TNF, PTGS1 and PTGS1. Recorded indications include Crow-Fukase (POEMS) syndrome, Erythema nodosum leprosum and Multiple myeloma.

• Approval status: ofp (first approved 1998 by the FDA).
• Molecular targets: TNF, PTGS1, PTGS1 and CRBN (7 listed in DrugCentral).
• Indications: Crow-Fukase (POEMS) syndrome, Erythema nodosum leprosum and Multiple myeloma.
• ATC code: L04AX02 (Other immunosuppressants).
• Molecular formula: C13H10N2O4; molecular weight 258.23 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (3)

• Crow-Fukase (POEMS) syndrome
• Erythema nodosum leprosum
• Multiple myeloma

Off-label uses (9)

• Actinic prurigo
• Discoid lupus erythematosus
• Erosive oral lichen planus
• Graft-versus-host disease
• Prevention of Recurrent Aphthous Stomatitis
• Pyoderma gangrenosum
• Recurrent aphthous ulcer
• Refractory upper gastrointestinal bleeding due to angiodysplasia
• Subacute cutaneous lupus erythematosus

Contraindications (10)

• Bradycardia
• Breastfeeding (mother)
• Deep venous thrombosis
• Epilepsy
• Neutropenic disorder
• Orthostatic hypotension
• Peripheral nerve disease
• Pregnancy, function
• Pulmonary thromboembolism
• Thromboembolic disorder

Mechanism & targets

Molecular targets (7)

Target	Gene	Action	Activity
Tumor necrosis factor	TNF	unknown	IC50 8.00
Prostaglandin G/H synthase 1	PTGS1	unknown	IC50 6.43
Prostaglandin G/H synthase 1	PTGS1	unknown	IC50 6.43
Protein cereblon	CRBN	modulator	EC50 6.39
Prostaglandin G/H synthase 2	PTGS2	unknown	IC50 6.30
Prostaglandin G/H synthase 2	PTGS2	unknown	IC50 6.30
Cereblon isoform 4	—	unknown	Ki 5.36

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2021-02-24	PMDA	—	Fujimoto Pharmaceutical Corporation	Yes
2008-04-16	EMA	—	Bristol-Myers Squibb Pharma EEIG
1998-07-16	FDA	—	CELGENE	Yes

ATC classification

ATC code	Therapeutic hierarchy
L04AX02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Other immunosuppressants

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Disease progression	3667.3
Death	3658.1
Neuropathy peripheral	2319.3
Plasma cell myeloma	1938.8
Deep vein thrombosis	793.7
Plasma cell myeloma recurrent	748.0
Malignant neoplasm progression	728.9
Human chorionic gonadotropin increased	612.1
Osteonecrosis	581.8
Pneumonia	480.9
Plasmacytoma	462.4
Renal failure	413.6

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Thalidomide is on its molecule page.

• Molecular formula: C₁₃H₁₀N₂O₄
• Molecular weight: 258.23 g/mol
• CAS number: —
• InChIKey: UEJJHQNACJXSKW-UHFFFAOYSA-N
• PubChem CID: 5426

O=C1N(C2CCC(=O)NC2=O)C(=O)C2=C1C=CC=C2

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Thalidomide used for?

DrugCentral lists the following indications for Thalidomide: Crow-Fukase (POEMS) syndrome, Erythema nodosum leprosum and Multiple myeloma.

How does Thalidomide work?

Its molecular targets in DrugCentral include TNF, PTGS1, PTGS1 and CRBN (modulator).

When was Thalidomide first approved?

Thalidomide was first approved by the FDA in 1998.

What is the chemical formula of Thalidomide?

Thalidomide has the molecular formula C13H10N2O4 and a molecular weight of 258.23 g/mol.

Sources

• DrugCentral drug card 2616 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL468 — compound record and bioactivity
• PubChem CID 5426 — chemical identifiers
• DrugBank DB01041 — drug record
• FDA UNII 4Z8R6ORS6L — substance identity
• DailyMed: FDA labels for Thalidomide — current prescribing information (label search)
• UniProt P01375 (TNF) — target protein
• UniProt P23219 (PTGS1) — target protein
• UniProt Q96SW2 (CRBN) — target protein
• UniProt P35354 (PTGS2) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.