What is Ledipasvir?

Ledipasvir, also sold under the common name of Harvoni, is an antiviral medicine used to treat certain types of Hepatitis C disease and liver malfunctioning in adults and children aged three years and above. Ledipasvir API is generally used in combination with Sofosbuvir as an antiviral medicine.

Sofosbuvir falls under the medication category called nucleotide polymerase inhibitors that reduces the growth of the Hepatitis C virus inside the human body. On the other hand, Ledipasvir falls under the category of medication called HCV NS5A inhibitors, which prevent the growth of Hepatitis C from spreading in the body. 

Here’s the chemical structure of ledipasvir API:

The other chemical details of ledipasvir API are as follows:

Chemical Formula: C49H54F2N8O6

Molar Mass: 888.99 

CAS Number: 1256388-51-8


IUPAC Name: methyl N-[(2S)-1-[(6S)-6-[5-[9,9-difluoro-7-[2-[(1R,3S,4S)-2-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]-2-azabicyclo[2.2.1]heptan-3-yl]-3H-benzimidazol-5-yl]fluoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbamate

SMILES: COC(=O)N[C@@H](C(C)C)C(=O)N1CC2(CC2)C[C@H]1C3=NC=C(N3)C4=CC=C5C(=C4)C(F)(F)C6=C5C=CC(=C6)C7=CC8=C(C=C7)N=C(N8)[C@@H]9[C@H]%10CC[C@H](C%10)N9C(=O)[C@@H](NC(=O)OC)C(C)C

What are the Most Common Uses of Ledipasvir?

There are multiple uses of Ledipasvir API:

  • Ledipasvir and Sofosbuvir tablets are used to treat the Hepatitis C virus in adults and children above three years. 
  • Ledipasvir can also be used as a combination therapy to treat chronic Hepatitis C, an infectious condition caused by the Hepatitis C virus. 

Organizations and Clinical Trials of Ledipasvir

124 organizations clinically tested Ledipasvir API for research and development purposes. However, one organization also tested it for marketing purposes. The trials were conducted in four stages, and a total of 1123 trials were conducted to test ledipasvir API for medicinal purposes. 

Clinical trial data

A few organizations that took part in those trials were:

  • Gilead Sciences
  • Jhonson & Jhonson
  • Genuine Research Centre, Egypt

Indications of Ledipasvir

There are two approved indications of Ledipasvir API:

  • Hepatitis C
  • Hepatitis C, Chronic

There are 27 experimental indications of the ledipasvir API as concluded in the four trials:

  • beta-Thalassemia (Phase 4)
  • Carcinoma, Hepatocellular (Phase 4)
  • COVID-19 (Phase 4)
  • Cryoglobulinemia (Phase 2/Phase 3)
  • Fibrosis (Phase 4)
  • Gaucher Disease (Phase 4)
  • Healthy Volunteers (Phase 1)
  • Heart Failure (Phase 4)
  • Hematologic Neoplasms (Phase 1/Phase 2)
  • Hematopoietic Stem Cell Transplantation (Phase 4)
  • Hepacivirus (Phase 3)
  • Hepatitis (Phase 1)
  • Hepatitis B (Phase 3)
  • Hepatitis C ()
  • Hepatitis C, Chronic ()
  • HIV (Phase 4)
  • HIV Infections (Phase 4)
  • Insulin Resistance (Phase 4)
  • Liver Cirrhosis (Phase 3)
  • Liver Diseases (Phase 4)
  • Lung Diseases, Interstitial (Phase 4)
  • Lymphoma (Phase 2)
  • Lymphoma, B-Cell (Phase 2)
  • Porphyria Cutanea Tarda (Phase 2)
  • Pregnancy (Phase 1)
  • Pulmonary Disease, Chronic Obstructive (Phase 4)
  • Substance Abuse, Intravenous (Phase 3)

Read Also: Everything You Need to Know about Apremilast

Safety and Hazards for Ledipasvir and Sofosbuvir API

Pictogram(s): Health Hazard

Signal: Warning

GHS Hazard Statements: H371 (100%)

Precautionary Statement Codes: P260, P264, P270, P308+P316, P405, and P501

Pharmacology of Ledipasvir

Mechanism of Action: Non-structural Protein 5A Inhibitor

Black Box: No  

Pro Drug: No

ALogP: 8.61

Delivery Methods: Oral

Protein Building: >99.8%

Half-life: 47 hours

Common Side Effects of Ledipasvir

Although ledipasvir API has many excellent benefits in treating Hepatitis C disease, some common side effects are seen with some patients taking this medication. To name a few, we have:

  • tiredness
  • headache
  • difficulty falling asleep or staying asleep
  • Nausea
  • diarrhea

Who Should Not Take Ledipasvir?

Ledipasvir and Sofosbuvir API have shown tremendous effects in treating Hepatitis C conditions in adults. However, there are some limitations to the people consuming this medicine.

  • Patients allergic to Sofosbuvir and Ledipasvir must not use this medicine
  • Women who are pregnant, planning to become pregnant, or are breastfeeding must consult with their doctors before taking Ledipasvir. 
  • Patients who are on dialysis, have HIV, or have had a liver transplant must consult their doctors before using Ledipasvir medicine. 

How to Store and Dispose of Ledipasvir?

Ledipasvir should always be stored in an air-tight container and out of reach of children. You should also store ledipasvir API at room temperature, away from light, and free from excess moisture.

Since this medicine is highly active, it should also be disposed of in special conditions. You must never throw away unused drugs in the toilet or water bodies. Instead, you must follow the medicine take-back program to dispose of the remaining medicine. You can check the FDA’s Safe Disposal of Medicine website to learn more about the medicine take-back program.


API manufacturers commonly use Ledipasvir API to create medicine for treating Hepatitis C conditions. Ledipasvir API is used with Sofosbuvir to cure adults and children above three years. The medicine has a molar mass of 888.99 and is sold by the name Harvoni.

Ledipasvir API was clinically tested in four phases, and 124 organizations participated in those trials. The most common side effects experienced by the patients consuming Ledipasvir and Sofosbuvir are headache, tiredness, and cough. Sometimes, rashes can also be seen in some patients. People who are allergic or pregnant must limit themselves from consuming Ledipasvir drugs. 


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