This section highlights FDA-related milestones and regulatory updates for drugs developed by Spero Therapeutics (SPRO).
Over the past two years, Spero Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Tebipenem, tebipenem, and SPR720. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Tebipenem FDA Regulatory Timeline and Events
Tebipenem is a drug developed by Spero Therapeutics for the following indication: Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
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:
- Tebipenem
- Announced Date:
- December 19, 2025
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 2026
- Indication:
- Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
Announcement
Spero Therapeutics, Inc announced that The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026.
AI Summary
Spero Therapeutics said its partner GSK has filed a New Drug Application (NDA) resubmission to the U.S. FDA for tebipenem HBr, an investigational oral carbapenem antibiotic for complicated urinary tract infections, including pyelonephritis. That NDA submission triggers a $25 million milestone payment to Spero, which the company expects to receive in Q1 2026. This payment represents a near-term cash event tied directly to the regulatory submission.
The resubmission is supported by positive late-stage trial results, and Spero has granted GSK exclusive commercialization rights in most territories, while Meiji keeps rights in certain Asian markets. Select tebipenem HBr studies were partly funded by federal sources including HHS, ASPR and BARDA under contract HHSO100201800015C. The announcement highlights a major upcoming payment for Spero linked to the drug’s regulatory progress.
Read Announcement- Drug:
- Tebipenem
- Announced Date:
- December 19, 2025
- Indication:
- Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
Announcement
Spero Therapeutics, Inc announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.
AI Summary
Spero Therapeutics said its development partner GSK filed an NDA resubmission with the U.S. Food and Drug Administration for tebipenem HBr, an investigational oral carbapenem being developed to treat complicated urinary tract infections, including pyelonephritis. The filing triggers a $25 million milestone payment to Spero, expected in Q1 2026. GSK’s resubmission is supported by results from the Phase 3 PIVOT-PO trial, which was stopped early for efficacy after a planned interim analysis in May 2025 and whose results were presented at IDWeek in October 2025.
Spero has granted GSK exclusive rights to commercialize tebipenem HBr in most territories, while Meiji retains rights in certain Asian markets. Select tebipenem HBr studies were partly funded by federal agencies, including HHS/ASPR and BARDA under contract HHSO100201800015C. The NDA resubmission is a key step toward possible regulatory approval and future commercialization.
Read Announcement- Drug:
- Tebipenem
- Announced Date:
- October 14, 2025
- Indication:
- Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
Announcement
Spero Therapeutics announces presentations on tebipenem Hbr at the upcoming IDWeek annual meeting to take place Oct 19 – 22, 2025 in Atlanta, GA.
AI Summary
Spero Therapeutics will present data on tebipenem HBr at the IDWeek annual meeting from October 19–22, 2025 in Atlanta. This oral carbapenem, developed with GSK, targets complicated urinary tract infections including pyelonephritis.
On October 20 from 1:45–3:00 PM ET, David K. Hong will present Phase 3 PIVOT-PO results comparing oral tebipenem to intravenous imipenem-cilastatin in the “Late Breaking Trial Results for Viral and Bacterial Infections” session in room B401-B402.
On October 21 from 12:15–1:30 PM, two posters in Hall B4–B5 will highlight tebipenem’s in vitro activity against Enterobacterales isolates from urinary tract and bloodstream infections in the United States.
Tebipenem HBr aims to reduce hospital stays by offering a convenient oral treatment for serious infections. Spero has granted GSK global commercialization rights outside parts of Asia.
Read Announcement- Drug:
- Tebipenem
- Announced Date:
- May 28, 2025
- Indication:
- Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
Announcement
Spero Therapeutics, announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, met its primary endpoint and will stop early for efficacy (NCT06059846).3
AI Summary
Spero Therapeutics recently announced that its pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an oral treatment for complicated urinary tract infections (cUTIs) including pyelonephritis, met its primary endpoint and will stop early for efficacy. An independent data monitoring committee reviewed information from 1,690 patients and confirmed that tebipenem HBr was non-inferior to the standard intravenous therapy of imipenem-cilastatin in terms of overall patient response—measured by both clinical cure and clearance of bacteria. The trial also showed that the oral treatment has a safety profile similar to previous studies, with diarrhea and headache being the most common adverse events.
GSK, Spero’s development partner, plans to include this positive data in a U.S. FDA filing expected in the second half of 2025. These results mark a significant advancement toward offering an effective, convenient oral option for U.S. patients who are treated for cUTIs, potentially reducing the need for hospital-based intravenous therapy.
Read Announcement- Drug:
- Tebipenem
- Announced Date:
- March 27, 2025
- Indication:
- Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
Announcement
Spero Therapeutics provided a business update.
AI Summary
Spero Therapeutics recently provided a business update emphasizing its focus on advancing tebipenem HBr for complicated urinary tract infections (cUTI). The company is preparing for a pre-specified interim analysis of the Phase 3 PIVOT-PO trial in Q2 2025. Spero believes that, if approved, this oral carbapenem could meet a critical unmet need by shortening hospital stays, improving patient outcomes, and reducing pressure on healthcare resources.
Alongside the tebipenem HBr program, Spero is reviewing the full data set from its Phase 2 study for SPR720 and has decided to discontinue the SPR206 program following a pipeline review. With funding from existing cash resources and milestone payments from GSK, the company is well positioned to support its operations until Q2 2026 as it moves forward with its clinical development efforts.
Read Announcement
Tebipenem HBr FDA Regulatory Events
Tebipenem HBr is a drug developed by Spero Therapeutics for the following indication: Patients with Complicated Urinary Tract Infections (cUTIs).
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:
- tebipenem HBr
- Announced Date:
- October 21, 2025
- Indication:
- Patients with Complicated Urinary Tract Infections (cUTIs)
Announcement
Spero Therapeutics, Inc. and GSK plc announced efficacy and safety results of the positive pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis (NCT06059846).
AI Summary
Spero Therapeutics and GSK announced positive results from the Phase 3 PIVOT-PO trial of tebipenem HBr, an oral treatment for complicated urinary tract infections (cUTIs) including pyelonephritis. The study was stopped early because it met the main goal of showing oral tebipenem was as effective as intravenous imipenem-cilastatin.
In hospitalized patients, oral tebipenem (600 mg) achieved a 58.5% overall success rate (clinical cure plus bacterial eradication) compared to 60.2% with IV imipenem-cilastatin (500 mg). The adjusted difference of –1.3% fell within the trial’s non-inferiority margin. Safety profiles were similar, with mild to moderate diarrhea and headache reported most often in the tebipenem group.
These data will be shared with regulators to support filings. If approved, tebipenem HBr could become the first oral carbapenem available in the U.S. for patients with cUTIs, reducing the need for hospital stays and IV therapy.
Read Announcement
SPR720 FDA Regulatory Events
SPR720 is a drug developed by Spero Therapeutics for the following indication: Nontuberculous mycobacterial (NTM) disease.
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:
- SPR720
- Announced Date:
- October 2, 2024
- Indication:
- Nontuberculous mycobacterial (NTM) disease
Announcement
Spero Therapeutics, announced the publication of data from its Phase 1 clinical trial, which assessed the intrapulmonary pharmacokinetics (PK) of SPR719.
AI Summary
Spero Therapeutics recently published promising data from its Phase 1 clinical trial in Antimicrobial Agents and Chemotherapy. The study focused on the intrapulmonary pharmacokinetics (PK) of SPR719, the active molecule derived from the oral prodrug SPR720. In this trial, healthy volunteers received SPR720, and researchers measured SPR719 levels in the lung’s epithelial lining fluid and alveolar macrophages—areas where mycobacteria live and multiply. The results showed that SPR719 successfully reached the lung compartment, achieving higher concentrations in these key areas compared to plasma. No unexpected safety issues were observed during the study, which provides valuable dose selection information for developing SPR720 as a treatment for lung infections caused by resistant bacteria.
Spero’s data supports ongoing studies to target multi-drug resistant bacteria effectively, and further research will confirm these promising results.
Read Announcement
