NCT07437547 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating pentadecapeptide BPC-157 for the treatment of acute grade II hamstring muscle strain, confirmed by MRI. Sponsored by Hudson Biotech and conducted at Peking University Shenzhen Hospital, the trial started in February 2026 and is currently recruiting 120 participants. The co-primary endpoints are time to return to unrestricted sport and change in MRI-assessed hamstring injury volume at Day 14.

Is NCT07437547 an FDA-regulated trial?

No. NCT07437547 is registered as a study of a non-FDA-regulated drug product. The trial is sponsored by Hudson Biotech, a China-based organization, and is conducted at a single site in Shenzhen, China. BPC-157 does not hold an Investigational New Drug (IND) designation from the FDA for this indication. The trial's existence is relevant to the July 2026 FDA PCAC review of BPC-157's 503A compounding classification, but it is a separate regulatory proceeding.

Why is BPC-157 being studied for hamstring injury specifically?

Preclinical research — primarily rodent models from the Sikiric laboratory and independent groups — has documented BPC-157 effects on tendon fibroblast VEGF upregulation, angiogenesis, and musculoskeletal tissue healing. Hamstring strain is a common sports injury with no established pharmacological intervention for accelerating structural repair, making it a clinically relevant and scientifically justified indication to evaluate. NCT07437547 is designed to test whether the preclinical findings translate to measurable structural and functional outcomes in humans.

What are the primary endpoints of NCT07437547?

NCT07437547 has two co-primary endpoints: (1) time to return to unrestricted sport participation in days, defined as clearance by a blinded sports medicine clinician after completing a standardized functional performance battery without pain-limited stopping, assessed over 8 weeks; and (2) change from baseline to Day 14 in MRI-assessed hamstring injury volume in cm³, measured by blinded central radiology review. The MRI volume endpoint is notable because it provides an objective structural measure of tissue change rather than relying solely on functional or self-reported outcomes.

BPC-157 NCT07437547: Phase 2 Clinical Trial for Hamstring Muscle Strain — What Researchers Need to Know

A randomized, double-blind, placebo-controlled Phase 2 trial of pentadecapeptide BPC-157 (NCT07437547) for acute hamstring muscle strain is currently recruiting, marking the first formally registered controlled human study of this compound in a musculoskeletal injury indication. This article summarizes the trial design, endpoints, and what researchers should understand about its scientific context.

All content here is drawn from the publicly registered trial record at ClinicalTrials.gov and published preclinical literature. Nothing here constitutes medical advice or guidance for human use.

Trial Overview

ClinicalTrials.gov identifier: NCT07437547
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Pentadecapeptide BPC 157 for Accelerated Repair of Acute Grade II Hamstring Strain Confirmed by MRI
Sponsor: Hudson Biotech
Study start: February 2, 2026
Primary completion (estimated): February 2027
Enrollment target: 120 participants
Phase: 2
Status: Recruiting
Location: Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

Background: Why Hamstring Injury?

Acute hamstring strains represent one of the most common soft tissue injuries in running and field-based sports, and are associated with prolonged recovery times and a high recurrence rate. Standard-of-care management relies primarily on structured rehabilitation programs; there is no pharmacological intervention with strong Phase 3 evidence for accelerating structural repair or shortening return-to-play timelines.

BPC-157's preclinical profile makes it a biologically plausible candidate for this indication. Published animal-model data has repeatedly reported effects on tissue-repair pathways. Chang et al. (Journal of Applied Physiology, 2011) demonstrated upregulated VEGF expression and increased tubule formation in tendon fibroblast cultures. Staresinic et al. (Journal of Orthopaedic Research, 2003) reported significantly accelerated Achilles tendon healing in rats after transection, with histological improvements in collagen fiber organization. A substantial body of work from the Sikiric laboratory has documented similar effects across multiple musculoskeletal models in rodents, covering tendons, ligaments, and bone.

The mechanistic proposals center on: (1) VEGF-mediated angiogenesis, which may accelerate vascular infiltration of injured tissue; (2) EGR-1 transcription factor activation, which modulates downstream repair-gene expression; and (3) nitric oxide system interactions affecting inflammatory resolution. None of these mechanisms has been validated in controlled human trials prior to NCT07437547.

See the BPC-157 compound library entry for full molecular data and the preclinical literature summary.

Trial Design

The study uses a parallel-group, 1:1 randomization design. Participants receive either investigational pentadecapeptide BPC-157 or matching placebo via subcutaneous injection once daily for 14 days, administered by trained study staff. Both arms follow the same evidence-based rehabilitation protocol supervised by study physiotherapists. All four parties — participant, care provider, investigator, and outcomes assessor — are blinded. Emergency unblinding is permitted only for safety reasons.

Eligibility (key inclusion criteria):

Age 18–45 years
Acute posterior thigh pain consistent with hamstring strain, onset within 72 hours of screening
MRI-confirmed grade II hamstring strain (biceps femoris, semitendinosus, or semimembranosus) with measurable lesion
Physical activity ≥3 sessions/week or organized recreational sport participation
Willingness to complete all study visits and follow the standardized rehabilitation protocol

Key exclusion criteria:

Grade III hamstring tear, avulsion, or injury requiring surgery
Prior hamstring strain on the same limb within 6 months
Concomitant use of systemic corticosteroids, anabolic agents, platelet-rich plasma, stem-cell products, or investigational peptides/growth factors within 30 days
Current participation in anti-doping testing programs (WADA/USADA-aligned) unless explicitly approved by the relevant authority

Primary Endpoints

The trial uses two co-primary endpoints:

Time to return to unrestricted sport participation (days): Defined as clinician clearance combined with completion of a standardized functional performance battery without pain-limited stopping. Assessed up to 8 weeks.
Change from baseline to Day 14 in MRI-assessed hamstring injury volume (cm³): Measured by blinded central radiology review. This is the structural endpoint — designed to detect whether BPC-157 treatment is associated with objectively measurable differences in lesion resolution on imaging.

The choice of an MRI-based structural endpoint at Day 14 is methodologically notable. It allows quantification of anatomical repair independent of subjective symptom reporting and creates a clear biological bridge to the preclinical models in which histological assessment was the primary evidence of effect.

Secondary Endpoints

Secondary measures assessed over 56 days include:

Pain during activity on a 0–10 Numeric Rating Scale (NRS)
Hamstring strength limb symmetry index (LSI) by isokinetic dynamometry
Change in Lower Extremity Functional Scale (LEFS; 0–80 scale)

The 3-month post-return-to-play follow-up for recurrence monitoring is an additional observation period, extending the total study completion estimate to February 2028.

Safety Monitoring

An independent Data and Safety Monitoring Committee (DSMC) will review unblinded safety data at predefined intervals. Safety assessments include adverse event monitoring, vital signs, and standard laboratory tests. The exclusion of participants already in WADA/USADA-aligned testing programs reflects recognition that BPC-157 is not currently approved by any major anti-doping authority, and that its detection status in competitive sport contexts is unresolved.

Regulatory Context

NCT07437547 is registered as a study of a non-FDA-regulated drug product, consistent with its China-based sponsor and trial location. BPC-157 does not have regulatory approval from the FDA, EMA, or comparable agencies for any therapeutic use.

In the United States, BPC-157 holds a 503A Category 2 compounding classification and is subject to FDA Pharmacy Compounding Advisory Committee (PCAC) review scheduled for July 23, 2026. The existence of this Phase 2 trial — even outside the US regulatory framework — is likely to be cited in PCAC proceedings as evidence that formal controlled evaluation is now underway, which is one of the factors considered in the four-factor PCAC analysis for clinical significance.

For a detailed analysis of the July 2026 PCAC implications, see: BPC-157 and the July 2026 FDA PCAC Review.

What This Trial Does and Does Not Establish

Phase 2 trials are designed to generate preliminary evidence of efficacy and to characterize safety — they are not adequately powered to confirm clinical benefit at the level required for regulatory approval. NCT07437547's enrollment target of 120 participants positions it as a signal-detection study. A positive signal would support advancement to a larger Phase 3 trial; a negative result would clarify whether the extensive rodent-model literature translates to the human musculoskeletal injury setting.

The trial's single-site, China-based design limits immediate generalizability. The sponsor, Hudson Biotech, is not a major pharmaceutical developer with published Phase 3 experience, and the trial has not been awarded an IND (Investigational New Drug) designation by the FDA. Researchers should interpret any results with these contextual factors in mind.

Notably, this trial does not address the other indication clusters present in BPC-157's preclinical literature — gastrointestinal protection, neurological models, and systemic stress responses. Even a successful outcome in the musculoskeletal-injury indication would not constitute evidence of efficacy in those separate domains.

Research Significance

NCT07437547 represents the first randomized controlled trial of BPC-157 in a well-defined musculoskeletal injury population with MRI-based structural endpoints. This methodological step — moving from rodent histology to human imaging — is the critical translational threshold that separates "preclinical signal" from "clinical candidate." The trial's completion (estimated February 2027 for primary outcomes) will be a definitive data point for researchers evaluating BPC-157's translational prospects.

For researchers tracking BPC-157's clinical development trajectory, the ClinicalTrials.gov record can be monitored directly at NCT07437547.

Related resources:

BPC-157 compound library entry — molecular data, mechanism summary, and preclinical literature
BPC-157 and the July 2026 FDA PCAC Review — regulatory access implications
BPC-157 vs TB-500 Comparison — mechanistic comparison with another tissue-repair peptide

All content on ClinicalPeptide.org is intended for researchers and educators working in biochemistry, pharmacology, and related disciplines. Nothing here constitutes medical advice or guidance for human self-administration of any compound.