Protein synthesis is a core biological process that primarily includes transcription and translation, and results in structural changes in organisms. Changes to the primary structure of a protein can result in the protein misfolding or malfunctioning and often could be the cause of underlying diseases. Protein synthesis inhibitors inhibit bacterial protein synthesis by interfering with the 30s or 50s ribosomal subunit, thereby inhibiting the bacterial protein synthesis which include initiation, formation of the 70s and elongation process of making polypeptides. Protein synthesis inhibitors are indicated for gram-positive infections, impetigo, skin and soft tissue infections, bacterial infections, malaria, bacterial vaginosis, chronic myeloid leukemia, community-acquired pneumonia, tuberculosis, and others. Novartis AG, Bausch Health, Teva Pharmaceuticals, GSK, AstraZeneca, and Pfizer are some of the major players in the protein synthesis inhibitors market.
Key Market Developments:
- In Mar 2022, Medicines and Healthcare Products Regulatory Agency (MHRA) accepted RS Oncology’s CTA for Thiostrepton for malignant pleural effusion in the UK.
- In Mar 2023, Aceragen received patent protection for Fusidic acid in the USA, Japan, and Canada.
Approved Drug Molecules with Brand Names of Protein Synthesis Inhibitors:
- Clarithromycin
- Clindamycin Phosphate
- Artemether/Lumefantrine
- Minocycline
- Gentamicin Sulfate
- Linezolid oral
- Synribo (Omacetaxine Mepesuccinate)
- Linezolid IV
- Quinine Sulfate
- Indapamide
- Taksta (Fusidic Acid)
- Xenleta (Lefamulin oral)
- Azelex (Azelaic acid)
- Fucicort (Fusidic acid/ Betamethasone valerate)
- Fucidin (Fusidic acid)
Drugs under the Pipeline for Protein Synthesis Inhibitors:
- Pretomanid (PA-824)
- Altabax (Retapamulin)
- Lumoxiti (Moxetumomab Pasudotox)
- Delpazolid (LCB01-0371)
- Fosmanogepix (APX001)
- Nafithromycin (WCK 4873)
- MT-3724
- Acoziborole (SCYX-7158)
- Benzoyl Peroxide/Clindamycin/Adapalene (IDP-126)
- Benzoyl Peroxide/Tretinoin (IDP-120)
- Cadazolid (ACT-179811)
- Ganaplacide/Lumefantrine (KLU156)
- Rylaze (Recombinant Erwinia Asparaginase)
- S6G5T-3
- Vicineum (Oportuzumab Monatox)
- Amlodipine/Indapamide/Telmisartan (GMRx2)
- Zifanocycline (KBP-7072)
- CRS3123
- KRN-5500
- T-Guard (SPV-T3a-RTA/WT1-RTA)
- Twyneo (3% Microencapsulated Benzoyl Peroxide/0.1% Microencapsulated Tretinoin)
- Xenleta (Lefamulin IV)
- Bizaxofusp (MDNA55)
- Ranpirnase ophthalmic (OKG-0301)
- Combotox (Imtox19/Imtox22)
- EDP-788
- MT-5111
- OXS-1550
- Proxinium (Oportuzumab Monatox Intratumoral)
- TBI-223
- Apramycin (EBL-1003)
- AWZ1066S
- Epsolay (Microencapsulated Benzoyl Peroxide cream 5%)
- INM176
- LFF-571
- MT-0169
- MT-6402
- SL-101
- Citatuzumab bogatox (VB6-845)
- Flubentylosin (ABBV-4083)
- Thiostrepton (RSO-021)
Clinical Activity and Developments of Protein Synthesis Inhibitors:
Currently, there are a total of 56 drug products in the protein synthesis inhibitors, including more than 15 approved drugs and others are in the clinical development phases.
In Nov 2022, Novartis conducted phase-III clinical trials in malaria for Artemether/Lumefantrine in Democratic Republic of the Congo, Mali, and Burkina Faso.
In Jan 2023, Nabriva Therapeutics completed a phase-I trial in cystic fibrosis in the USA for the drug Lefamulin.
|
Molecule Name |
Number of Studies |
|
Pretomanid (PA-824) |
30 |
|
Altabax (Retapamulin) |
21 |
|
Lumoxiti (Moxetumomab Pasudotox) |
18 |
|
Delpazolid (LCB01-0371) |
11 |
|
Fosmanogepix (APX001) |
11 |
|
Nafithromycin (WCK 4873) |
6 |
|
MT-3724 |
5 |
|
Acoziborole (SCYX-7158) |
5 |
|
Benzoyl Peroxide/Clindamycin/Adapalene (IDP-126) |
5 |
|
Benzoyl Peroxide/Tretinoin (IDP-120) |
5 |
|
Cadazolid (ACT-179811) |
5 |
|
Ganaplacide/Lumefantrine (KLU156) |
5 |
|
Rylaze (Recombinant Erwinia Asparaginase) |
4 |
|
S6G5T-3 |
4 |
|
Vicineum (Oportuzumab Monatox) |
4 |
|
Amlodipine/Indapamide/Telmisartan (GMRx2) |
4 |
|
Zifanocycline (KBP-7072) |
4 |
|
CRS3123 |
3 |
|
KRN-5500 |
3 |
|
T-Guard (SPV-T3a-RTA/WT1-RTA) |
3 |
|
Twyneo (3% Microencapsulated Benzoyl Peroxide/0.1% Microencapsulated Tretinoin) |
3 |
|
Xenleta (Lefamulin IV) |
3 |
|
Bizaxofusp (MDNA55) |
3 |
|
Ranpirnase ophthalmic (OKG-0301) |
3 |
|
Combotox (Imtox19/Imtox22) |
2 |
|
EDP-788 |
2 |
|
MT-5111 |
2 |
|
OXS-1550 |
2 |
|
Proxinium (Oportuzumab Monatox Intratumoral) |
2 |
|
TBI-223 |
2 |
|
Apramycin (EBL-1003) |
2 |
|
AWZ1066S |
1 |
|
Epsolay (Microencapsulated Benzoyl Peroxide cream 5%) |
1 |
|
INM176 |
1 |
|
LFF-571 |
1 |
|
MT-0169 |
1 |
|
MT-6402 |
1 |
|
SL-101 |
1 |
|
Citatuzumab bogatox (VB6-845) |
1 |
|
Flubentylosin (ABBV-4083) |
1 |
|
Thiostrepton (RSO-021) |
1 |
Target Indication Analysis of Protein Synthesis Inhibitors:
Protein synthesis inhibitors such as Clarithromycin, Erythromycin, and others are used in the treatment of acute otitis media caused by H. influenza, M. catarrhalis, or S. pneumonie in patients. Also, for the treatment of pharyngitis and tonsillitis caused by susceptible Streptococcus pyogenes, as well as respiratory tract infections including acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, helicobacter pylori infections, and others. Some of the other drug molecules are in the clinical phase trials for conditions like Crohn’s disease, mycobacterium avium complex infections, nontuberculous mycobacterium infections, multiple sclerosis, head and neck cancer, non-small cell lung cancer, solid tumors, and others.
Regional Analysis of Protein Synthesis Inhibitors:
Protein Synthesis Inhibitors Market
According to the World Health Organization’s malaria report 2021, globally, there were estimated 241 million malaria cases in 2020 in 85 malaria endemic cases, where most of the increase came from countries in the WHO Africa Region, which accounted for 95% of cases, and the WHO Soth-East Asia Region India accounted for 83% of estimated cases. An estimated global total of 10.6 million people fell ill with TB in 2021, and geographically, most TB cases were in South-East Asia (45%), Africa (23%), and the Western Pacific (18%), with smaller shares in the Eastern Mediterranean (8.1%), the Americas (2.9%), and Europe (2.2%). Also, there is a growing concern about gram-positive infections and related antimicrobial resistance.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Clarithromycin, Clindamycin Phosphate, Artemether/Lumefantrine, Minocycline, Gentamicin sulfate, Linezolid oral, and Synribo (Omacetaxine Mepesuccinate) are some of the approved protein synthesis inhibitors.
Novartis AG, Bausch Health, Teva Pharmaceuticals, GSK, AstraZeneca, and Pfizer are some of the major players in the protein synthesis inhibitors market.
Major indications for protein synthesis inhibitors are gram-positive infections, impetigo, skin and soft tissue infections, bacterial infections, malaria, bacterial vaginosis, chronic myeloid leukemia, community-acquired pneumonia, tuberculosis.
There are a more than 40 molecules that are in the clinical development phases for protein synthesis inhibitors.
- Novartis AG
- Bausch Health
- Teva Pharmaceuticals
- GSK
- AstraZeneca
- Pfizer
- Nabriva Therapeutics
- Sumitomo Pharma
- J&J
- CARISMA Therapeutics
- Sihuan Pharmaceutical
- AbbVie
- Enanta Pharma
- LEO Pharma