Study of Tecovirimat for Human Mpox Virus (STOMP)

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease

The purpose of this study was to see if tecovirimat is safe and successful at treating mpox. The main questions were whether tecovirimat reduced time to lesion resolution and pain compared to placebo (no treatment).

Study Overview

• Status: Terminated
• Conditions: MPOX
• Intervention / Treatment: Drug: Tecovirimat Oral Capsule; Drug: Placebo for Tecovirimat; Drug: Tecovirimat Oral Capsule (Open Label)

Detailed Description

This phase 3, randomized, placebo-controlled, double-blind clinical trial evaluated the efficacy of tecovirimat for the treatment of mpox. Participants who had or were at higher risk for severe disease because of their age or medical history, were pregnant or breastfeeding, or were taking medications that could have decreased their exposure to tecovirimat were assigned to receive open-label tecovirimat for 14 days. All other participants were randomized 2:1 to receive either tecovirimat or placebo for 14 days.

Randomized participants who reported severe pain 5 days after randomization (on Day 6) or later or progressed to severe disease stopped blinded study treatment and started a 14-day course of open-label tecovirimat.

Participants self-monitored lesions daily through 28 days (Day 29) or resolution, whichever came first, and completed a daily pain scale and symptom diary. Study visits occurred weekly through 28 days (Day 29) and included safety and skin assessments and specimen collections. A final study visit occurred at 56 days (Day 57) to assess for recrudescence of infection (development of new lesions after initial resolution of disease).

Version 3 of the protocol gave participants the option to enroll and complete study visits remotely. Participants did not provide specimens at remote visits.

On November 26, 2024, the Data and Safety Monitoring Board (DSMB) recommended that the study close due to statistical futility. The study team and sponsor agreed with the DSMB's recommendation and the study closed to accrual on November 27, 2024. The primary analysis report forming the basis of the primary manuscript used data from follow-up visits occurring through October 23, 2024, the data cutoff for the November 2024 DSMB review (the primary completion date). Outcome measures submitted to clinicaltrials.gov were also based on data from follow-up visits occurring through October 23, 2024, and summaries of participant flow, baseline characteristics, and adverse events submitted to clinicaltrials.gov were based on data from follow-up visits occurring through February 22, 2025 (the study completion date).

• Study Type: Interventional
• Enrollment (Actual): 719
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Fundacion Huesped CRS
• Brazil
  • São Paulo, Brazil
    • Centro de Pesquisas Clínicas IC-HCFMUSP CRS
• Mexico
  • Mexico City, Mexico
    • Nutricion Mexico CRS
• Peru
  • Callao, Peru
    • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) CRS
  • Lima, Peru
    • Barranco CRS
  • Lima, Peru
    • San Miguel CRS
  • Lima, Peru
    • Socios en Salud Sucursal Peru
  • Lima, Peru
    • Via Libre CRS
• Thailand
  • Bangkok, Thailand
    • Thai Red Cross Aids Research Centre
  • Bangkok, Thailand
    • Vaccine Trial Centre, Mahidol University CRS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama CRS
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90035
      • UCLA CARE Center CRS
    • Los Angeles, California, United States, 90028
      • Los Angeles LGBT Center CRS
    • Sacramento, California, United States, 95817
      • University of California, Davis CRS
    • San Diego, California, United States, 92103
      • UCSD Antiviral Research Center CRS
    • San Francisco, California, United States, 94110
      • University of California, San Francisco HIV/AIDS CRS
    • Torrance, California, United States, 90502
      • Harbor University of California Los Angeles Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital CRS
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver NICHD CRS
    • Denver, Colorado, United States, 80204
      • Denver Public Health CRS
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Jacksonville NICHD CRS
    • Miami, Florida, United States, 33136
      • University of Miami / Jackson Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Univ. of South Florida (USF) College of Medicine A
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • The Ponce de Leon Center CRS
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Cook County Hospital Chicago NICHD CRS
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University CRS
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital CRS (MGH CRS)
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital Therapeutics
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital CRS
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University Therapeutics (WT) CRS
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School Clinical Research Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Uptown CRS
    • New York, New York, United States, 10010
      • Weill Cornell Chelsea CRS
    • New York, New York, United States, 10019
      • Mount Sinai West Samuels CRS
    • New York, New York, United States, 10027
      • Harlem Prevention Center
    • New York, New York, United States, 10032
      • Columbia Physicians & Surgeons (P&S) CRS
    • New York, New York, United States, 10457
      • Bronx-Lebanon Hospital Center NICHD CRS
    • New York, New York, United States, 11029
      • Infectious Disease Clinical and Translational Research
    • Rochester, New York, United States, 14642
      • University of Rochester Adult HIV Therapeutic
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook NICHD CRS
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center CRS
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center CRS
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati CRS
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University CTU
    • Columbus, Ohio, United States, 43210
      • Ohio State University CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Therapeutics CRS
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh CRS
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital ATN CRS
  • Texas
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Disease Consultants
    • Dallas, Texas, United States, 75390
      • UT Southwestern Infectious Disease Research Unit
    • Houston, Texas, United States, 77030
      • Houston AIDS Research Team (HART) CRS
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Positive Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (All participants; Arms A, B, and C):

1. Laboratory-confirmed or presumptive human mpox virus (HMPXV) infection.
2. HMPXV illness of <14 days duration immediately prior to study entry.
3. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers.
4. Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation.
5. Ability to provide informed consent (for those above the legal age of consent and those providing consent for minors) and assent (for those who have reached the age of assent, but not the legal age of consent), as allowed by local ethics committees.
6. For participants to be enrolled/followed remotely, ability and willingness to participate in remote telehealth assessments (i.e., video visits).

Additional Inclusion Criteria for Arms A and B:

1. Age ≥18 years at the time of study entry.

Additional Inclusion Criteria for Arm C:

Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C.

1. Age <18 years at the time of study entry.

2. Those with severe HMPXV disease defined as having one or more of the following conditions:

   • Suspected or confirmed ocular involvement
   • Facial lesions on the malar, nose, or eyelid region
   • Confluent facial lesions
   • Hospitalization due to HMPXV infection or its complications
   • Lesions that require surgical intervention including debridement, urinary catheterization or sigmoidoscopy, or lesions extending below the dermis.

Those with or without severe disease and with one or more of the following:

• Severe immunosuppression
• Active skin conditions placing the person at higher risk for disseminated infection
• Breastfeeding
• Pregnancy
• Receipt of potent inducers
• Current or planned use of another investigational drug at any point during tecovirimat/placebo dosing that would be predicted to have a significant drug-drug interaction with tecovirimat therapeutics.

Exclusion Criteria (All participants; Arms A, B, and C):

1. Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism.
2. Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who were stable on long-acting intramuscular cabotegravir/rilpivirine were allowed to enroll.
3. Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study.
4. Participants who require intravenous dosing of tecovirimat.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tecovirimat (Arm A); Participants randomized to tecovirimat.	Drug: Tecovirimat Oral Capsule; Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days; Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days; Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
Placebo Comparator: Placebo (Arm B); Participants randomized to placebo.	Drug: Placebo for Tecovirimat; Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days; Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days; Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
Experimental: Open-Label Tecovirimat (Arm C); Participants assigned to open-label tecovirimat.	Drug: Tecovirimat Oral Capsule (Open Label); Participants weighing <3 kg - Tecovirimat 33.3 mg every 12 hours for 14 days; Participants weighing 3 kg to less than 6 kg- Tecovirimat 50 mg every 12 hours for 14 days; Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days; Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days; Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days; Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days; Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Proportion With Clinical Resolution by Day 29	Clinical resolution defined as all skin lesions scabbed, desquamated, or healed, and visible mucosal lesions healed. The cumulative incidence of clinical resolution was estimated using the Aalen-Johansen estimator. The treatment effect, i.e., the subdistribution hazard ratio of tecovirimat relative to placebo, was estimated using the Fine and Gray subdistribution proportional hazards model. All-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024.	From study entry through 28 days of follow-up (i.e., Day 29)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Time-weighted Average of Pain Intensity Difference Over 5 Days of Treatment	Pain was measured on 11-point numerical rating scale (NRS) where 0 = no pain and 10 = worst possible pain. Pain intensity difference at ith day of treatment (i = 2, ..., 6) calculated as NRS pain score at baseline (last available pre-treatment) minus NRS pain score on ith day of treatment Time-weighted average of pain intensity difference over 5 days of treatment was a weighted average of the pain intensity difference from treatment day 2 to treatment day 6, where the weights were calculated as the duration in days between the ith day of treatment and the day of the previous measurement. The lowest possible value that this could have been was -10, which would have indicated an increase in pain by 10 points on average over 5 days of treatment. The highest possible value that this could have been was +10, which would have indicated a decrease in pain by 10 points on average over 5 days of treatment. Includes data from follow-up visits occurring through October 23, 2024.	Through 5 days of treatment (i.e., Treatment Day 6)
Mean Time-weighted Average of Pain Intensity Difference Over 14 Days of Treatment	Pain was measured on 11-point numerical rating scale (NRS) where 0 = no pain and 10 = worst possible pain. Pain intensity difference at ith day of treatment (i = 2, ..., 15) calculated as NRS pain score at baseline (last available pre-treatment) minus NRS pain score on ith day of treatment Time-weighted average of pain intensity difference over 14 days of treatment was a weighted average of the pain intensity difference from treatment day 2 to treatment day 15, where the weights were calculated as the duration in days between the ith day of treatment and the day of the previous measurement. The lowest possible value that this could have been was -10, which would have indicated an increase in pain by 10 points on average over 5 days of treatment. The highest possible value that this could have been was +10, which would have indicated a decrease in pain by 10 points on average over 5 days of treatment. Includes data from follow-up visits occurring through October 23, 2024.	Through 14 days of treatment (i.e., Treatment Day 15)
Number of Participants Who Developed Severe HMPXV Disease	Severe HMPXV disease was defined as one or more of the following conditions: suspected or confirmed ocular involvement, facial lesions on the malar, nose, or eyelid region, confluent facial lesions, hospitalization due to HMPXV infection or its complications, or lesions that required surgical intervention including debridement, urinary catheterization, or sigmoidoscopy, or extended below the dermis.	From study entry through 56 days of follow-up (i.e., Day 57)
Number of Participants With HMPXV DNA Below Limit of Detection in Skin Lesions	HMPXV DNA was measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, 22, 29, and 57
Number of Participants With HMPXV DNA Below Limit of Detection in Oropharynx	HMPXV DNA was measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, 22, 29, and 57
Number of Participants With HMPXV DNA Below Limit of Detection in Rectum	HMPXV DNA was measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, 22, 29, and 57
Number of Participants With HMPXV DNA Below Limit of Detection in Blood	HMPXV DNA measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, 22, 29, and 57
Number of Participants With HMPXV DNA Below Limit of Detection in Vaginal Swabs	HMPXV DNA measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, 22, 29, and 57
Cumulative Proportion With Complete Lesion Healing by Day 29	Complete lesion healing was defined as all lesions re-epithelialized. The cumulative incidence of complete lesion healing was estimated using the Aalen-Johansen estimator. The treatment effect, i.e., the subdistribution hazard ratio of tecovirimat relative to placebo, was estimated using the Fine and Gray subdistribution proportional hazards model. All-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024.	From study entry through 28 days of follow-up (i.e., Day 29)
Number of Participants With no Missed Doses (of Last Three Prescribed Doses)	Since the adherence assessment was removed from protocol version 3.0, the number of participants with adherence data was expected to be small and no formal statistical comparison between treatment arms was done. Includes data from follow-up visits occurring through October 23, 2024.	Days 8 and 15
Median Change From Baseline in EuroQol (EQ) Visual Analogue Scale (VAS) Score	Participants' self-rated health measured on a visual analogue scale (VAS) where 0 = "The worst health you can imagine" and 100 = "The best health you can imagine." Change in EQ VAS score at each timepoint calculated as absolute change from baseline (last available pre-treatment). Includes data from follow-up visits occurring through October 23, 2024.	Days 8, 15, and 29
Number of Participants Who Reported Each Level of Response on Mobility Dimension of EuroQol EQ-5D-5L Questionnaire	Participants' self-reported health state within mobility dimension of the five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, and 29
Number of Participants Who Reported Each Level of Response on Self-Care Dimension of EuroQol EQ-5D-5L Questionnaire	Participants' self-reported health state within self-care dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, and 29
Number of Participants Who Reported Each Level of Response on Usual Activities Dimension of EuroQol EQ-5D-5L Questionnaire	Participants' self-reported health state within usual activities dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, and 29
Number of Participants Who Reported Each Level of Response on Pain/Discomfort Dimension of EuroQol EQ-5D-5L Questionnaire	Participants' self-reported health state within pain/discomfort dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, and 29
Number of Participants Who Reported Each Level of Response on Anxiety/Depression Dimension of EuroQol EQ-5D-5L Questionnaire	Participants' self-reported health state within anxiety/depression dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024.	Baseline, Days 8, 15, and 29
Proportion of Participants With Grade 3 or Greater Treatment-emergent Adverse Event	Study protocol required reporting of all adverse events (AEs) that (1) led to a change in study treatment regardless of grade, (2) met the serious AE (SAE) or Expedited AE (EAE) reporting requirement, and (3) were Grade 3 or greater. AEs were graded using the DAIDS AE Grading Table (Version 2.1). Severity Grade: 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Life-Threatening, 5 = Death Includes data from follow-up visits occurring through October 23, 2024.	Through 56 days of follow-up (i.e., Day 57)
Number of Participants Who Died From Any Cause	Includes data from follow-up visits occurring through October 23, 2024.	Through 56 days of follow-up (i.e., Day 57)
Tecovirimat Concentrations in Children Less Than 18 Years of Age	Plasma tecovirimat concentrations were quantified using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The lower limit of quantification was 5.0 ng/mL.	On Day 8, blood samples were collected pre-dose and at 1, 2, 3, 4, 6, 8, and 10 hours post-dose. On Day 15, a single blood sample was collected within 4 hours of study product administration.

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: SIGA Technologies
• Investigators: Study Chair: Timothy Wilkin, MD, MPH, Cornell

Publications and helpful links

General Publications

• Chenchula S, Atal S, Ghanta MK, Uppugunduri CR, Karunakaran S, Amerneni KC, Sarma P, Prakash S, Amerneni LS, Padmavathi R, Anitha K, Sri Varshini T, Vishnu Vardhan K, Kaore S, Sadasivam B. Emerging variants of Mpox virus and tecovirimat resistance: Genomic insights and implications for treatment strategies. Virology. 2025 Jul;608:110532. doi: 10.1016/j.virol.2025.110532. Epub 2025 Apr 12.

Helpful Links

• The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017
• DAIDS EAE Manual, Version 2.0

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): February 22, 2025

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: HMPXV
• Additional Relevant MeSH Terms: Infections; Virus Diseases; Poxviridae Infections; DNA Virus Infections; Animal Diseases; Primate Diseases; Rodent Diseases; Mpox, Monkeypox; Anti-Infective Agents; Antiviral Agents; tecovirimat
• Other Study ID Numbers: A5418; 38982 (Other Identifier: DAIDS-ES ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie results in the publication after deidentification
• IPD Sharing Time Frame: Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally (ACTG) by NIH

IPD Sharing Access Criteria

With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.

For what types of analyses? To achieve aims in the proposal approved by the ACTG.

By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No