PolyPid's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by PolyPid (PYPD).
Over the past two years, PolyPid has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
D-PLEX100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
D-PLEX100 FDA Regulatory Timeline and Events
D-PLEX100 is a drug developed by PolyPid for the following indication: Surgical Site Infections in Colorectal Surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- D-PLEX100
- Announced Date:
- April 13, 2026
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX₁₀₀ at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2026 (formerly known as ECCMID), the world's leading congress for clinical microbiology and infectious diseases, taking place on April 17-21, 2026, in Munich, Germany.
AI Summary
PolyPid Ltd. announced it will present new pharmacokinetic data from the Phase 3 SHIELD II trial at ESCMID Global 2026 (April 17–21, 2026, Munich). The abstract, titled “Pharmacokinetics of local extended‑release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co‑authored by Prof. Antonino Spinelli and PolyPid scientists.
Key findings show D‑PLEX₁₀₀ provides a sustained, controlled release with detectable doxycycline for up to 763 hours (about 32 days) after local application, and no initial drug burst. Systemic exposure was minimal: plasma doxycycline stayed below 100 ng/mL, far lower than typical oral doxycycline Cmax values (about 1,613 ng/mL for 100 mg and 2,600 ng/mL for 200 mg), roughly 16–26 times higher.
The abstract will be posted on PolyPid’s website after the conference for further review.Read Announcement
- Drug:
- D-PLEX100
- Announced Date:
- March 31, 2026
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that it has initiated a New Drug Application ("NDA") submission to the U.S. Food and Drug Administration (the "FDA") for D-PLEX₁₀₀ for the prevention of surgical site infections ("SSIs") in patients undergoing colorectal surgery.
AI Summary
PolyPid Ltd. announced it has begun a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for D-PLEX100, a treatment intended to prevent surgical site infections (SSIs) in patients undergoing colorectal surgery. The company presented this submission as part of its pathway to bring the therapy to U.S. hospitals.
The NDA is being filed under the FDA’s Fast Track designation, which permits a rolling review process. PolyPid said it has submitted the Chemistry, Manufacturing and Controls (CMC) and nonclinical modules first. Additional sections, including the clinical module, are planned for submission in the second quarter of 2026.
PolyPid expects the NDA review to be completed in the second quarter of 2026 and noted that negotiations for a U.S. commercialization partnership are on track as it advances the regulatory process.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- March 17, 2026
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $4.3 million for the New Drug Application (NDA) for D-PLEX₁₀₀, the Company's lead product candidate for the prevention of surgical site infections (SSIs) in abdominal colorectal surgeries.
AI Summary
PolyPid Ltd. announced the U.S. Food and Drug Administration granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $4.3 million for its New Drug Application (NDA) for D-PLEX₁₀₀, the company's lead product candidate designed to prevent surgical site infections (SSIs) in abdominal colorectal surgeries. The waiver removes a significant upfront regulatory cost tied to the NDA filing.
With the fee waived, PolyPid says it can concentrate resources on commercialization preparations such as manufacturing scale-up, market access planning, and stakeholder outreach. The company is on track to initiate the NDA submission by the end of this month. If accepted, the submission would begin the formal FDA review process for D-PLEX₁₀₀ and could speed progress toward making the product available for surgeons and patients at risk of postoperative infections.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- December 3, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that it has received a formal pre-New Drug Application ("NDA") meeting minutes from the U.S. Food and Drug Administration ("FDA") supporting the NDA submission of D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries.
AI Summary
PolyPid Ltd. said it has received formal pre-New Drug Application (pre-NDA) meeting minutes from the U.S. Food and Drug Administration supporting an NDA submission for D-PLEX100, its lead candidate to prevent surgical site infections in abdominal colorectal surgeries. The FDA agreed that the company’s existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support an NDA submission and review. The agency also agreed to a rolling NDA review, which would let PolyPid submit the first completed sections in early 2026. Based on the FDA’s written response, PolyPid concluded the pre-NDA meeting objectives were met and canceled the in-person meeting planned for December 3, 2025.
D-PLEX100 is designed to deliver prolonged, local antibacterial activity at the surgical site by releasing the antibiotic doxycycline over about 30 days. In the Phase 3 SHIELD II trial, D-PLEX100 showed a statistically significant 58% relative risk reduction in surgical site infections after abdominal colorectal surgery with large incisions.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- September 30, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL.
AI Summary
PolyPid Ltd. announced that Dr. Shmuel Sharoni will present topline results from its successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the 2025 American College of Surgeons (ACS) Clinical Congress in Chicago. His talk is titled “Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The SHIELD II Phase 3 Randomized Clinical Trial.”
The presentation is scheduled for Sunday, October 5, 2025, at 11:30 AM Central Time during the “High Impact Clinical Trials and Studies” session (SF109). PolyPid’s management team will also be available for meetings throughout the conference held October 4–7 at McCormick Place.
The SHIELD II trial was a multinational, randomized, double-blind study that met its primary and all key secondary endpoints. When D-PLEX₁₀₀ was added to standard care, it achieved a 38% reduction in combined surgical site infections, reinterventions, or mortality (p < 0.005) and a 58% drop in infection rate (p < 0.005) compared to standard care alone.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- June 9, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA.
AI Summary
PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial evaluating D-PLEX100 to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions. The trial met its primary efficacy endpoint with statistically significant results (p<0.005) and showed a 58% reduction in SSIs compared to the standard of care. These outcomes highlight D-PLEX100’s potential to lower costs and improve patient care by reducing infection risk and supporting better clinical recovery.
The innovative product, which uses a controlled release of the antibiotic doxycycline at the surgical site, has received Fast Track designation from the U.S. Food and Drug Administration. PolyPid plans to submit a New Drug Application to the FDA in early 2026, aiming to offer a valuable new tool to address the significant unmet need in managing surgical site infections.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- June 6, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET.
AI Summary
PolyPid Ltd., a biopharma company focused on improving surgical outcomes, announced it will host a conference call and webcast on Monday, June 9, 2025 at 8:30 a.m. ET. During the call, the company will share topline data from the SHIELD II Phase 3 trial, which is testing D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
Attendees are advised to register at least five minutes before the start of the call to ensure a smooth connection. This event highlights an important step in evaluating how D-PLEX100 can help reduce post-surgery complications through precise, prolonged-release therapy. The conference call and webcast will provide key insights into the trial’s outcomes and PolyPid’s ongoing efforts to enhance surgical care. Participants can join the event using the provided web links.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- March 11, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
AI Summary
PolyPid Ltd. announced that it has successfully completed enrollment for its SHIELD II Phase 3 trial of D-PLEX100, a treatment aimed at preventing surgical site infections in patients undergoing abdominal colorectal surgery. The trial enrolled a total of 800 patients, following a recommendation from an independent Data Safety Monitoring Board after analyzing data from the initial 430 patients. This milestone marks a key step in evaluating D-PLEX100’s effectiveness in being administered alongside standard care during surgery.
The company expects to share top-line results by the end of the second quarter of 2025. If the data proves favorable, PolyPid plans to arrange a meeting with the FDA to discuss a rolling New Drug Application submission. This progress reinforces PolyPid’s commitment to improving surgical outcomes and reducing postoperative infection risks for patients undergoing complex abdominal surgeries.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- December 24, 2024
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced today that following the independent Data Safety Monitoring Board's ("DSMB") review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections ("SSIs") in patients undergoing abdominal colorectal surgery with large incisions, the DSMB's recommendation was to conclude the study upon enrollment of 800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients.
AI Summary
PolyPid Ltd. announced that an independent Data Safety Monitoring Board (DSMB) has reviewed unblinded efficacy data from the first 430 patients enrolled in the SHIELD II Phase 3 trial for D-PLEX100, which is designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery. Based on the review, the DSMB recommended that the study conclude enrollment at 800 patients. This figure represents the lowest sample size stop after the minimum planned 624 patients, suggesting that D-PLEX100 is showing promising efficacy signals. The DSMB’s decision also came with the flexibility to halt the trial early due to futility or overwhelming efficacy, or to increase the sample size to a maximum of 1,100 patients if needed. Additionally, the DSMB confirmed the good safety profile of D-PLEX100 observed so far during the trial.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- October 1, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that Top-line Results Anticipated in First Quarter of 2025
AI Summary
PolyPid Ltd., a late-stage biopharma company focused on improving surgical outcomes, announced progress in its Phase 3 SHIELD II trial for D-PLEX100. This trial is designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery. The company confirmed that the unblinded interim analysis will occur during the current quarter after the last patient completes the 30-day follow-up. Top-line results from the SHIELD II trial are anticipated in the first quarter of 2025. Enrollment is quickly progressing toward full capacity, which is expected by the end of the year. The upcoming analysis will be key in determining whether early trial conclusions can be made due to positive efficacy, or if the study should continue with additional recruitment and potential sample size adjustments. This milestone reflects PolyPid’s commitment to advancing innovative, locally administered antibiotic treatments for surgical patients.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- October 1, 2024
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that it has enrolled the last patient required in order to conduct the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
AI Summary
PolyPid Ltd. announced that it has enrolled the final patient needed to perform the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial. This study is testing D-PLEX100, a treatment designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The planned interim analysis will take place this quarter after all patients complete their 30-day follow-up period. The results of this analysis may allow the trial to end early if positive efficacy is observed or lead to adjustments in patient recruitment, which may ultimately increase the total number of subjects from the current count of approximately 430 to a planned 630. PolyPid aims to release top-line results from the SHIELD II trial in the first quarter of 2025.
Read Announcement
PolyPid FDA Events - Frequently Asked Questions
As of now, PolyPid (PYPD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, PolyPid (PYPD) has reported FDA regulatory activity for D-PLEX100.
The most recent FDA-related event for PolyPid occurred on April 13, 2026, involving D-PLEX100. The update was categorized as "New Data," with the company reporting: "PolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX₁₀₀ at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2026 (formerly known as ECCMID), the world's leading congress for clinical microbiology and infectious diseases, taking place on April 17-21, 2026, in Munich, Germany."
Currently, PolyPid has one therapy (D-PLEX100) targeting the following condition: Surgical Site Infections in Colorectal Surgery.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:PYPD last updated on 4/13/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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