Numerous clinical trials across Phase 1 through Phase 4 evaluate nirmatrelvir (PF-07321332) for the treatment and prevention of COVID-19, SARS-CoV-2 infections, and post-acute sequelae, alongside pharmacokinetic and bioavailability assessments in healthy volunteers and patients with chronic renal insufficiency. Sponsored by pharmaceutical leaders like Pfizer as well as international hospital and academic networks—including Chinese PLA General Hospital and Mount Sinai Hospital—these studies range from early safety evaluations to large-scale post-marketing effectiveness trials. Current recruitment statuses vary across the portfolio, encompassing completed, active recruiting, non-recruiting, terminated, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06441955 | RECRUITING | COVID-19, Long Haul |
Well- Konnect Healthcare Services and Research Firm |
2024-03-01 | PHASE4 |
| NCT05041907 | RECRUITING | COVID-19 |
University of Oxford |
2021-09-30 | PHASE2 |
| NCT06610643 | NOT_YET_RECRUITING | COVID-19; SARS-CoV-2; Immunocompromised |
National Taiwan University Hospital |
2024-09-21 | |
| NCT05261139 | RECRUITING | COVID-19 |
Pfizer |
2022-03-07 | PHASE3 |
| NCT02735707 | RECRUITING | Community-acquired Pneumonia, Influenza, COVID-19 |
UMC Utrecht |
2016-04-11 | PHASE3 |
| NCT06792214 | RECRUITING | SARS CoV-2 Post-Acute Sequelae |
Mount Sinai Hospital, Canada |
2025-01-03 | PHASE4 |
| NCT06397144 | WITHDRAWN | Biological Availability; Healthy Participants |
Pfizer |
2025-08-15 | PHASE1 |
| NCT05852873 | ACTIVE_NOT_RECRUITING | Post COVID-19 Condition, Unspecified; SARS-CoV2 Infection; COVID-19 |
Haukeland University Hospital |
2023-05-12 | PHASE3 |
| NCT04483960 | UNKNOWN | SARS-CoV-2 Infection (COVID-19) |
University of Melbourne |
2020-07-28 | PHASE3 |
| NCT05938140 | UNKNOWN | COVID-19; Renal Insufficiency, Chronic |
Chinese PLA General Hospital |
2023-06-22 | PHASE4 |
| NCT05386472 | TERMINATED | COVID-19 |
Pfizer |
2022-06-22 | PHASE1 |
| NCT05965726 | COMPLETED | Long COVID-19; Long COVID |
Kanecia Obie Zimmerman |
2023-07-26 | PHASE2 |
| NCT05823896 | COMPLETED | Post-COVID-19 Syndrome; Long COVID; Long Covid19; COVID-19; POTS - Postural Orthostatic Tachycardia Syndrome; Post COVID-19 Condition; Post-COVID Syndrome; Post COVID-19 Condition, Unspecified; Postinfectious Inflammation; Postinfectious Disorder |
Karolinska Institutet |
2023-05-01 | PHASE2 |
| NCT05668091 | COMPLETED | Long COVID |
Harlan M Krumholz |
2023-04-14 | PHASE2 |
| NCT05441215 | COMPLETED | Healthy Participants |
Pfizer |
2022-12-12 | PHASE1 |
| NCT05321394 | COMPLETED | COVID-19 |
Azienda Ospedaliera Universitaria Integrata Verona |
2022-03-07 | PHASE3 |
| NCT05567952 | COMPLETED | COVID-19 |
Pfizer |
2022-10-19 | PHASE2 |
| NCT05545319 | WITHDRAWN | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Coronavirus Disease 2019 (COVID-19); Immunocompromised; Hospitalization; Child, Hospitalized |
Pfizer |
2022-12-13 | PHASE2 |
| NCT05576662 | COMPLETED | Post-acute Sequelae of SARS-CoV-2 Infection; Long COVID |
Stanford University |
2022-11-08 | PHASE2 |
| NCT05898672 | COMPLETED | Pharmacokinetics; Healthy Volunteers |
Pfizer |
2023-06-09 | PHASE1 |
| NCT05438602 | COMPLETED | COVID-19 |
Pfizer |
2022-08-03 | PHASE2 |
| NCT05487040 | TERMINATED | COVID-19 |
Pfizer |
2022-09-07 | PHASE1 |
| NCT05697055 | UNKNOWN | COVID-19 |
Shandong Provincial Hospital |
2023-01-21 | PHASE4 |
| NCT05690646 | COMPLETED | Cardiac Surgery |
China National Center for Cardiovascular Diseases |
2023-01-28 | PHASE4 |
| NCT05813600 | COMPLETED | Omicron Variant of COVID-19 |
Xiangao Jiang |
2022-08 | |
| NCT05544786 | COMPLETED | Biological Availability |
Pfizer |
2022-09-28 | PHASE1 |
| NCT05525910 | COMPLETED | Biological Availability; Healthy Participants |
Pfizer |
2022-08-31 | PHASE1 |
| NCT05491330 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2022-08-21 | PHASE1 |
| NCT05487040 | Terminated | COVID-19 |
Pfizer |
2022-09-07 | Phase 1 |
| NCT05011513 | TERMINATED | COVID-19 |
Pfizer |
2021-08-25 | PHASE2; PHASE3 |
| NCT05366192 | COMPLETED | Safety Issues |
RenJi Hospital |
2022-05-06 | PHASE4 |
| NCT05601167 | COMPLETED | COVID-19 |
Promomed, LLC |
2021-02-17 | PHASE3 |
| NCT05263921 | COMPLETED | Bioavailability |
Pfizer |
2022-03-10 | PHASE1 |
| NCT05263895 | COMPLETED | Bioavailability |
Pfizer |
2022-03-03 | PHASE1 |
| NCT05339334 | COMPLETED | Healthy Participants |
Pfizer |
2022-03-10 | PHASE1 |
| NCT05047601 | COMPLETED | COVID-19 |
Pfizer |
2021-09-09 | PHASE2; PHASE3 |
| NCT05178654 | WITHDRAWN | Healthy Participants |
Pfizer |
2022-02-22 | PHASE1 |
| NCT05339334 | Completed | Healthy Participants |
Pfizer |
2022-03-10 | Phase 1 |
| NCT05263921 | Completed | Bioavailability |
Pfizer |
2022-03-10 | Phase 1 |
| NCT05129475 | COMPLETED | Healthy Participants |
Pfizer |
2021-11-12 | PHASE1 |
| NCT05032950 | COMPLETED | Healthy Participants |
Pfizer |
2021-09-17 | PHASE1 |
| NCT04960202 | COMPLETED | COVID-19 |
Pfizer |
2021-07-16 | PHASE2; PHASE3 |
| NCT05005312 | COMPLETED | Hepatic Impairment |
Pfizer |
2021-08-31 | PHASE1 |
| NCT05064800 | COMPLETED | Healthy Participants |
Pfizer |
2021-09-21 | PHASE1 |
| NCT05129475 | Completed | Healthy Participants |
Pfizer |
2021-11-12 | Phase 1 |
| NCT04962230 | COMPLETED | Healthy Participant |
Pfizer |
2021-07-15 | PHASE1 |
| NCT04909853 | COMPLETED | Renal Impairment |
Pfizer |
2021-06-15 | PHASE1 |
| NCT04962022 | COMPLETED | Healthy Participant |
Pfizer |
2021-07-20 | PHASE1 |
| NCT04756531 | COMPLETED | Healthy Participants |
Pfizer |
2021-02-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2024-11-27)
Check the
Nirmatrelvir (PF-07321332)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Nirmatrelvir (PF-07321332) Solubility in DMSO
- Nirmatrelvir (PF-07321332) Stock Solution
- Nirmatrelvir (PF-07321332) Storage
- Nirmatrelvir (PF-07321332) Stability
- Nirmatrelvir (PF-07321332) Molecular Weight
- Nirmatrelvir (PF-07321332) SMILES
- Nirmatrelvir (PF-07321332) CAS Number
- Nirmatrelvir (PF-07321332) Chemical Structure (2D and 3D)
- Nirmatrelvir (PF-07321332) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.